However, the overall condition of health-related hardware in Aboriginal community housing across NSW pre-intervention has not significantly changed during the program’s 20 years. Results suggest a systematic lack of routine maintenance and quality control continues to be the overwhelming cause for this lack of improvement pre-intervention. Our evaluation of the HfH program demonstrated that fidelity to a standardised housing testing and repair methodology to improve residents’ safety and health can have sustainable effects on housing infrastructure and associated health benefits, such as a 40% reduction in infectious disease hospital separations. Housing and health agencies should collaborate more closely on social housing programs and ensure programs are adequately resourced to address safety and health issues.Many studies document the relationship between housing quality and health status. Poor housing in Aboriginal communities continues to be linked to the compromised health status of Aboriginal Australians. The New South Wales (NSW) Housing for Health (HfH) program has been assessing and repairing Aboriginal community housing across the state for 20 years using a standardised intervention methodology that aims to improve the health of Aboriginal people in NSW by improving their living environments. Items are tested and repairs are prioritised to maximise safety and health benefits and measured against 11 Critical Healthy Living Priorities . Descriptive analysis of data collected pre- and post-intervention from 3670 houses was conducted to determine the effectiveness of the program. Analysis demonstrated statistically significant improvements in the ability of the houses to support safe and healthy living for all critical healthy living priorities post-interventions. Trend analysis demonstrated the magnitude of these improvements increased over 20 years. In 24 communities ( The World Health Organization (WHO) recognises poor housing as one of the main social causes of ill health ,2 and exWhile Australia is an economically developed country with a high standard of living ,7,8, pooThere are around 800,000 Aboriginal and Torres Strait Islander people in Australia, representing 3.3% of the total Australian population. Whilst in remote areas there are higher proportions of Aboriginal Australians, one-third of the Australian Aboriginal population lives in New South Wales (NSW), the most populous state in Australia ,20. The HfH is a structured process for surveying and fixing houses, developed by Healthabitat, a not-for profit organisation, in the early 1990s ,23. It hIn 1997 an interagency environmental health committee of NSW government agencies funded a trial HfH project in one discrete Aboriginal community in Northern NSW that demonstrated measurable improvement in the condition of those houses and ability to support healthy living. Consequently, a jointly funded program by NSW Health and the NSW Governments’ 10-year Aboriginal Communities Development Program (ACDP) expanded HfH to other NSW Aboriginal communities—usually a small town or a neighbourhood in a larger town . An evalThis paper aims to describe the development of the HfH program in NSW, provide an overview of the program methodology and an analysis of program data over 20 years, and discuss the benefits and limitations of the program.Housing for Health (HfH) projects  are run according to a standardised seven stage process ,27 whichIn NSW, projects are delivered continuously, and at any given time there are around 10–15 projects at various stages of implementation across the state. The selection of Aboriginal communities invited to participate in HfH (Stage 1) is primarily based on need determined from information on housing condition provided by PHUs, communities and government reports—and the availability of project resources at the time. Communities are not randomly selected.Community consultation and a feasibility assessment (Stage 2) is undertaken to consider logistical issues in delivering the project—such as employment of local workers, insurances and accommodation—and to obtain community consent prior to proceeding. Consultation is undertaken with the housing providers, community leaders and each household. Project establishment (Stage 3) informs residents, arranges local work opportunities by employing local community workers and tradespeople, purchases consumables, and prepares for the immediate fix during the next stages.Routine (maintenance reasonably expected in a house);Faulty , orDamage .Teams of trained community workers led by qualified team leaders, usually from local PHUs, undertake the initial baseline survey and fix (SF1). SF1 tests and records 268 items in each house using standardised, repeatable tests based on Australian standards and current best practice. The raw survey items provide useful information on specific issues in houses such as number of residents, number of taps working and hot water temperatures, and guides the repair works. Teams carry out minor repairs immediately such as replacing light globes and shower heads or unblocking sinks. The tradespeople—licenced plumbers and electricians—follow the teams within the next few hours repairing urgent and more complex items identified by the survey such as replacing hot water systems. There are some widely held beliefs about social housing being poorly looked after by the tenants, so the tradespeople are required to identify and record the cause for each repair being either:Larger, more complex works such as re-waterproofing showers or improving accessibility for elderly or disabled tenants are implemented over the next 4 to 18 months following SF1, with the length determined by the number and condition of houses.before any works completed and SF2 conducted after all works are completed. This is usually between six and 18 months later, depending on the amount of work required. SF2 facilitates repairs to any outstanding items since SF1 and enables an audit of the works in Stage 4 and Stage 5 by community teams. A report of the housing condition before and after each project, and a list of all works undertaken—by house and by trade—is compiled for each HfH project and provided to the community organisations at the completion of the project.Following the completion of the major repairs, a second survey and fix (SF2) is undertaken using the same survey instrument as SF1. This second survey and fix provides a data driven comparison between SF1 conducted As the program has been continuously delivered around the state of NSW for two decades, most of the larger Aboriginal community housing providers in both discrete and non-discrete Aboriginal communities have received a HfH project. In the second decade, some communities received a repeat HfH project. The time between first and second HfH projects ranges from five to 17 years, and timing was dependent on specific issues in those communities.Power, water, and waste connectedElectrical safetyGas safetyStructure and accessFire safetyShower working adequatelyFacilities to wash childrenLaundry servicesFlush toilet workingAll drains workingFacilities to store, prepare and cook foodThe program has a limited budget, so all works are prioritised to maximise the safety and health benefit to householders. Immediate life-threatening dangers are addressed as the highest priority, followed by repairs that ensure the house structure and hardware can support healthy living by the residents. Based on the literature, Healthabitat developed a practical implementation of evidence-based practices that support healthy living ,22. ThesWork is allocated in accordance with these priorities, but not all may be met at the completion of a HfH project given funding limitations.There are 268 raw items collected at survey and 41 items calculated based on the survey items, giving a total of 309 items per house. These items have response codes assigned to them with a score for each response: typically, 1 for a pass and 0 for a fail, although some items have slightly more complex scores.Each CHLP is measured by assigning a set of data items from the survey. For example, for a house to enable residents to wash effectively and to maintain hygiene and health, a shower in a house requires the following minimum seven items to be functioning: hot water; cold water; hot water at a safe but effective temperature; hot and cold water taps; a shower hose and adequate drainage . The CHLThe percentage of houses where CHLPs were fully met, i.e., a house’s score for a CHLP equaled the maximum possible CHLP score, therefore fully meeting the standard.The percentage of houses where CHLP scores were within specified ranges i.e., Good (100% of maximum score); Fair (50% to 99% score) and Poor (less than 50%). This method was used for analysis in Two methods were used to calculate summary statistics for a set of houses:Survey data from 112 HfH projects from 1998–2017 were analysed using SAS Enterprise Guide software, Version 9.4 . DescripThe percentage of houses where a CHLP was fully met was calculated as a binomial proportion for all HfH projects in the relevant time period. A 95% confidence level interval for the binomial proportion was constructed using the normal approximation. To compare the percentages of CHLPs fully met between SF1 and SF2, the proportions of houses before and after intervention were tested for marginal homogeneity for matched pairs using the McNemar test statistic at 95% confidence level . A matchThe HfH projects were grouped into 5-year intervals based on completion dates for each project and an average across the CHLP scores was calculated to determine trends over time. For each CHLP we assessed whether there was a linear trend in the percentage fully met across an ordered factor . This analysis was applied separately at SF1 and SF2 and the Cochran–Armitage trend test statistic was used at 95% confidence level .n = 802 houses, n = 24 projects) to compare CHLP scores over time within the same community.Separate analysis was undertaken for those communities that had a repeat HfH project (Over the 20-year period (1998–2017), the NSW Housing for Health (HfH) program conducted 113 HfH community projects (or interventions) in 3670 houses with a resident population of 14,609 people. In total, 88 communities (2791 houses) received at least one HfH project from 1998 to 2017. Of these 88 communities, 24 (802 houses) had a second project between five and 17 years later. One community had a third project implemented but it is not included in this analysis.n = 112). If one or more criteria failed in a house, the house was not considered to adequately support that CHLP item.At the initial survey (SF1), safety in houses was low, particularly electrical safety (7.5%), structure and access (23%) and fire safety (29%). For those houses with gas, just over half (56%) met the safety requirements. With regard to washing people, only 39% of all houses had all items in the shower working and two thirds of houses had a place to wash a small child with all hardware working . Only 29% of houses had laundry facilities to support the washing of clothes and bedding. This includes the hardware and space to install a washing machine safely but does not include the washing machine itself as this is considered a tenant responsibility in social housing. Only two thirds of houses had flush toilets working properly, and 21% had all drainage working. Improving nutrition is assessed by whether houses support the ability of residents to prepare, cook and store food safely. Only 9% of houses had all items in this CHLP category working at SF1.P < 0.01) revealed significant improvement in the percentage of houses meeting each CHLP from SF1 to SF2 in all categories. Following SF2, a score of at least 75% was attained for all but two of the CHLPs, with four CHLPs exceeding a score of 90%. The biggest improvement was in electrical safety, with only 7% meeting this CHLP at SF1 and 87% at SF2. Whilst the ability to store, prepare, and cook food was improved more than 4-fold, only 39% of houses had all items working at the end of the projects.Chi-squared analysis  program over a 20-year period from 1998 to 2017. The research demonstrated significant improvements in the condition of houses and the ability to meet critical healthy living priorities (CHLPs) due to the HfH project intervention . Not allMost CHLPs achieved greater than 75% compliance after the HfH project intervention. However, results are generally lower for the lower priority CHLPs largely because of HfH program budgetary constraints restricting improvement on expensive items.Each CHLP comprises a set number of items and a house must pass all these items to achieve that CHLP goal. Occasionally, achieving a maximum score for all CHLP items is beyond the scope of the HfH program funding and not all items are fixed. For example, fire safety in all houses was upgraded to current standards for smoke detection, but in some houses, security screens had been permanently fixed to the building frame, increasing security but preventing egress (fire escape) from windows.Whilst the facilities to store, prepare and cook food were improved more than four-fold due to the HfH project intervention, only 39% of houses had all items working after the intervention. Budgetary constraints limited the ability to improve all items within this CHLP, particularly in the first decade of the program. The results of Survey-Fix2 (SF2) are a measure of the effectiveness of the HfH project intervention to improve house function over the past 20 years. Trend analysis of the overall SF2 data post-intervention  indicateEvaluation of house function is built into the methodology of the NSW HfH program for each HfH project but quantifying the impact of the HfH program on health outcomes is challenging. A 10-year evaluation of the program assessed changes in hospital admissions before and after each project. The analysis linked hospital admissions data to all houses in the HfH program over the first decade and demonstrated a 40% reduction in hospital separations for environmentally related infectious diseases for those residents of houses included in the HfH program compared to a control population . A summaSurvey-Fix 1 (SF1) data describes of the condition of housing before any work was undertaken as part of the HfH intervention. The HfH program has surveyed and fixed around 70% of the NSW Aboriginal community housing sector, presenting a picture of the housing condition in the sector over 20 years. The ability of Aboriginal community housing in NSW to support basic safety and healthy living priorities prior to a HfH project was below 40% across all houses  and trenThe failure of housing management systems is a likely reason for this lack of improvement in house function in Aboriginal communities over the past two decades see . NSW HfHAlthough the average condition of houses at SF1 across all 112 HfH projects shows very little change over 20 years,  the 24 lData from communities that received a repeat HfH project demonstrates significant improvement in the condition of the houses after each intervention (from SF1 to SF2). The improvement between SF2 results at the end of the first and second interventions is consistent with the general improvements in project delivery over the life of the program, illustrated in The results of the HfH program assessment of evidence-based housing safety and health priorities presented here demonstrates significant improvements in the home environments over two decades. For disadvantaged families where unemployment is high, the home environment is often the environment where people spend most of their time. Ensuring the homes’ ability to support health is associated with significant reduction in the rates of infectious diseases, which in turn can reduce the risk factors for many chronic diseases, such as renal and cardiac disease, both of which are overrepresented in the Aboriginal population ,20,31. TImproving health outcomes should reduce health expenditure on preventable conditions. “The cost of poor housing is borne by the health system”  and, whiMuch has been published on the connection of housing and health in the international literature. In the context of industrialised economies, much of the modern literature relates to urbanisation, energy efficiency, temperature control (particularly in cold environments), and indoor air quality issues such as mould and chemical exposures ,34,35,36A strength of the HfH program has been the consistent collection of detailed data on houses in Aboriginal communities over an extended period. Whilst the primary purpose of the data is to guide repair work for each HfH project, the consolidated data provides evidence that can inform social housing policy and program delivery. Despite the gains demonstrated over the past 20 years, the HfH program does not address all issues in the homes. An average budget of only $9220 per house (Consumer Price Index (CPI) adjusted) has limited the HfH program’s ability to improve all items in houses, and more detailed analysis of the HfH program data may help identify specific items for repair that provide further improvements to the CHLPs.The HfH program does not focus on social housing issues such as tenancy and long-term asset management. Its primary focus is on improving health by providing a level of attention to detail on hardware items that improve safety and health in houses, and these items are a basic standard that could be applied to all social housing. Telfar-Barnard et al. described a household “warrant of fitness” assessment for all rental housing in New Zealand to ensure basic measures of habitability are met,  similar Analysis of the Housing for Health (HfH) program data has demonstrated significant improvements in critical healthy living priorities in Aboriginal community housing in NSW where the program has been implemented. The magnitude of these improvements has increased over 20 years and results indicate sustainability of improvements for most priorities. The NSW HfH program’s collection of consistent data over this time provides a repository of information which can guide future policy and program development. Despite the benefits from the HfH program, across NSW there has been little change over two decades in the poor standard of safety and health hardware in Aboriginal homes prior to the HfH projects. A lack of routine maintenance and faulty design or construction is overwhelmingly the key cause identified for the failure of items repaired under the program. This data suggests the systems for maintenance of health hardware in Aboriginal community housing over the past 20 years have not improved healthy living priorities. This lack of improvement may be contributing to the gap in Aboriginal health compared to the rest of the Australian population. The specification of quality health hardware in maintenance programs is likely to be a cost-effective investment in both housing and health in the long term. Fidelity to a detailed HfH program methodology of standardised testing and repair of defined items that improve safety and health has led to these significant and sustainable improvements in house function in Aboriginal communities over the past 20 years of the HfH program in NSW. The effectiveness of the HfH program has improved significantly over the second decade, suggesting the substantial improvements in health outcomes associated with the first decade of the HfH program  will lik


Biomechanical studies of walk, especially walk on the circle, are scarce, while circles or curved tracks are frequently used during equestrian activities. To study horse–rider–circle interactions on the circle, the first steps would be to investigate how the unridden, freely walking horse is influenced by circular movement, and then add a rider. The aim was to study horse vertical trunk movements, and sagittal cannon angles (protraction–retraction) during walk in straight-line and on the circle without rider, and on the circle with a rider using minimal influence.p < 0.05.Ten horses were ridden by five riders, summing to 14 trials. Each trial included straight walk unridden (on concrete), and walk on 10 m diameter circles (left and right on soft surface) first lunged (unridden) and then ridden with minimal rider influence. Inertial measurement units (100 Hz) were positioned on the withers, third sacral vertebra (S3) and laterally on metacarpal and metatarsal bones (using self-adhesive bandage). Selected data were split in steps  or strides (cannon protraction–retraction) at maximum hind limb protraction, and range of motion (ROM), minima and maxima, and their timing, were extracted. Data were analyzed using mixed models with inner/outer/straight nested within unridden/ridden as fixed effect, and controlling for stride duration. Differences between: inner vs outer steps/limbs; the same step/limb unridden vs ridden; and the same step/limb straight vs inner/outer unridden; were examined for statistical significance at Inner limbs had smaller cannon ROM than outer limbs, for example, forelimbs when ridden (inner vs outer 62° vs 63°) and hind limbs when unridden (53° vs 56°). Forelimb cannon ROM was the largest for straight (65°). Hind limb ROM for straight walk (55°) was in-between inner (52–53°) and outer hind limbs (56–57°). Vertical ROM of S3 was larger during the inner (unridden/ridden 0.050/0.052 m) vs the outer step (unridden/ridden 0.049/0.051 m). Inner (0.050 m) and outer steps (0.049 m) unridden had smaller S3 ROM compared to straight steps . Compared to when unridden, withers ROM was smaller when ridden: inner hind steps unridden/ridden 0.020 vs 0.015 m and outer hind steps 0.020 vs 0.013 m. When ridden, withers ROM was larger during the inner hind step vs the outer.The outer hind limb had greater cannon pro-retraction ROM, compared to the inner limb. Larger croup ROM during the inner step appears to be coupled to increased retraction of the outer hind limb. Knowledge of magnitudes and timing of the horse’s movements on the circle in unridden and ridden walk may stimulate riders to educate eye and feel in analyzing the execution of circles, and stimulate further studies of the walk, for example, on interactions with rider influence, natural horse asymmetries, or lameness. The straight walk is a symmetrical four-beat gait with alternating bipedal and tripedal support phases, that is, either two limbs or three limbs are in contact with the ground . This rem. longissimus dorsi showed that muscle activity was four to five times greater on the inside compared to at the straight, and that the outside muscle activity decreased compared to straight.Riders will strive to achieve straightness , which mThe aim of the current study was to explore differences in vertical excursion of the forehand and hindquarters, and in limb pendulation, between inner and outer limbs, in horses walking on a circle unridden, and ridden with minimal rider influence, as well as unridden in straight line. The study focused on vertical translation of the withers and the third sacral vertebra (S3), and sagittal metacarpal and metatarsal bone angles, approximating limb protraction and retraction. The hypotheses were that variable values for straight walk would be in-between those for outer and inner steps, that angular ROM (protraction–retraction) of the cannon bones of the outer limbs would exceed those of the inner limbs, and that the addition of a rider would influence the forehand variables more than hind quarter variables.The experiment took place at one stable, using 10 horses that had been stabled there for at least 2 months. Data on breed, gender, age, withers height, and duration with the present owner were assembled . The horFive right-handed riders participated; one of them was a trainer and the others her students. The riders were all female, aged between 18 and 57 years, with weights and heights ranging between 61–66 kg and 158–173 cm. The riders had been training regularly with the trainer for at least 4 years. All riders were accustomed to their mounts. Riders wore helmets and all carried a dressage whip (rarely used during the experiment), but spurs were not used. All riders except one rode two or more horses. Four horses were ridden by two riders . There whttps://x-io.co.uk/ngimu/) were positioned on the withers, above the third sacral vertebra (S3), and laterally on the metacarpal and metatarsal (cannon) bones of both fore- and hind limbs, using self-adhesive bandages (https://x-io.co.uk/ngimu/). The experiments were video-recorded (Sony FDR-AX53) at 25 Hz; when recording trials on the circle the camera was placed in the middle of the circle, and head/tail view was used for straight line. In order to synchronize the video with the IMU measurements, the sensors were tapped before and after each trial, positioned together on a stool placed in front of the camera.Inertial measurement units (IMU) . The horse was then lunged on the marked circle by the rider in free walk until the horse had completed at least one circle in steady walk per direction. After that the rider mounted and rode the horse in free walk on the circle. When the trial was finished the sensors were removed, tapped for synchronization, and then the video camera stopped. The rider rode with loose reins while still guiding the horse to follow the circle. Left and right leads were alternated, such that the horses were either lunged unridden in left-right lead order and ridden in right-left lead order, or in the opposite. Left/right order was consistent for all horses within each measurement day but was reversed between days. Warming-up between unridden and ridden conditions was minimal: walking from the mounting block to the circle (<20 strides). One to five trials were performed per day, but each horse only performed one trial per day. Four horses performed the experiment twice (with different riders), with approx. 5 month between. Only one horse was in the arena during data collection.The videos were scrutinized by authors AE and AB. Data handling was done using Matlab . Straight line data were selected from two of the longest and straightest moving walk sequences out of 2–4 recorded. Data from the circle were selected as an uninterrupted sequence, usually 0.5–1 circle, when the horse was moving as freely and harmonious as possible and following the circle, with minimal active influence from the lunge line or the rider. Data from selected sequences were split into steps  or strides (cannon angles) based on the maximum pitch angle for each hind limb cannon bone, approximating ground contact times of this limb. When stride-split data were used, strides from circles were split on the inner hind limb cannon pitch maximum, and strides from straight walk on left hind limb cannon pitch maximum. Stride/step curves for all used steps were plotted and visually inspected. Duration (in s) of each stride was calculated. Data were time-normalized to 100 points/indices.ROM, minima and maxima, and timing of those extreme points relative to hind limb cannon maximum pitch (protraction), were calculated from step-normalised vertical position data for the withers and S3, and from stride-normalised pitch data for the cannons. These were deemed the most relevant and reliable kinematic variables extractable from the IMU data. Maximum and minimum cannon pitch angles will be referred to as maximum protraction and maximum retraction, respectively, in the results section. Step/stride minima and maxima were extracted automatically; because the vertical position data for S3 and the withers  were more noisy, outlier removal was applied as follows, to only include data with a correct outtake of extreme points: for withers minimum position and its timing, data points were only included if minima were found between 60% and 95% of the step, and for withers maximum only if between 10% and 50%. For S3 minimum and its timing, data were included if found between 10% and 50% of the step, and for S3 maximum between 50% and 100%. These constraints were selected based on the expected timing of those extreme points in a normal walk. For withers this resulted in that 33–46% of the data points were removed and for S3 data 2–11% of the data points were removed. Timing values were adjusted by 50% (of the stride) as necessary in order for values to be directly comparable between inner/outer/straight step or limb values. For straight line data left and right steps/limbs were then pooled.p-value limit for statistical significance was set to <0.05. P-values were not adjusted for multiple comparisons.Descriptive and analytical statistics were made using SAS . Stride duration was entered as a linear covariate in all models after verifying that no curved or modal pattern could be suspected when plotting stride duration against the outcome variables. The general random parameter structure consisted of rider, horse, the interaction between horse and rider, and exercise  within rider-horse combination. The option pdiff (in the MIXED procedure) was used for extracting least square means and selected pairwise comparisons. The following two-way comparisons were evaluated: (a) inner vs outer step/limb variable values, separately for unridden and ridden conditions; (b) the same step/limb variable  between unridden vs ridden; and (c) the same variable between straight vs inner or outer . Straight was not compared to ridden. For minimum and maximum vertical positions only (a) comparisons were made . The The following two groups of models were created:(1) In order to study the vertical excursion of the trunk, withers and S3 ROM, and values for and timing of minima and maxima, were analyzed with each observation/step labeled as an inner, outer or straight step. The fixed categorical effect evaluated was step (inner/outer/straight) nested within unridden/ridden.For minimum and maximum value evaluation an extra random effect was added: stride serial number nested within the three-way interaction between horse, rider and exercise, enabling the comparison of inner and outer step minima/maxima within condition (unridden/ridden) on a stride by stride basis.(2) In order to study cannon bone protraction–retraction (pitch), ROM and values for and timing of minima and maxima were analyzed using stride-normalised data. The fixed categorical effect evaluated was limb  nested within unridden/ridden.For cannon maximum protraction and maximum retraction angles an extra random effect was added: the three-way interaction between horse, rider and horse side (left/right) nested within exercise, to account for slight differences in sensor alignment with the cannon bone on left and right limbs.Additionally, a model with stride duration as outcome was made, with the same general random parameter structure. Fixed effects were circle/straight nested within unridden/ridden, and hind limb cannon ROM. Stride duration was plotted vs hind limb cannon ROM to confirm reasonable linearity vs the outcome.To achieve normality of residuals the following steps were taken. If mean and medians were close, standard deviations (SDs) relatively small and skewness and kurtosis close to zero, variables were analyzed in untransformed formats. If this was not the case, variables were Box Cox transformed and the best practical transformation for each variable was adopted. Residual plotting was employed in a last step to ensure that only few standardized (Pearson) residuals had absolute values above three.In total there were 14 trials  from 10 horses ridden by 5 riders, each riding 1–5 horses. Each trial included unridden walk in hand on straight line and on the lunge on left and right circles, and then ridden walk on circles. In the overall dataset, for each horse/rider combination  there were between 13 and 26 strides of straight walk (median 18 strides), 4–49 strides of unridden walk on the circle to the left (median 13 strides), 6–25 strides of unridden walk on the circle to the right (median 12 strides), 4–34 strides of ridden walk on the circle to the left (median 7.5 strides) and 4–33 strides of ridden walk on the circle to the right (median 11 strides). Descriptive data for stride duration are found in p-values p < 0.0001, except for: in the timing of withers minimum model stride duration the p-value was 0.10; in the timing for withers maximum model circle/straight within unridden/ridden was associated with p = 0.0005; in the timing of maximum protraction model stride duration was associated with p = 0.24; and in the maximum protraction model stride duration was associated with p = 0.002. Data distributions, including number of steps or strides, for the variables analyzed are illustrated using boxplots in p-values <0.01 and italics 0.01 < p < 0.05). For example, for both unridden (p = 0.001) and ridden conditions (p = 0.03), S3 ROM was larger during the inner step, compared to the outer step (p = 0.009) and the hind limbs both when unridden  and ridden .Detailed results for withers and S3 vertical position variables can be found in ter step . For intter step . For canter step  there wep = <0.0001, 28.2% + 50 < 79.1%, figures from the third and fourth last rows of Withers and S3, and cannon angle timing variables are summarized in p < 0.0001. Stride duration was shorter for straight compared to on the circle, but there was a minuscule (p = 0.30) difference between when ridden and unridden. The coefficient for hind limb cannon ROM was −0.011 s/°, suggesting that stride duration decreased with increasing cannon ROM.In the stride duration model, circle/straight within unridden/ridden and hind limb cannon protraction-retraction ROM were both associated with In the current study the intent was to investigate the effects of circular movement at walk with minimal influence from other factors, such as the handler or a rider. It could be assumed that values for straight line would be in-between inner steps and outer steps on the circle, but for some variables estimates for straight-line walk fell outside that range. S3 ROM, and forelimb cannon ROM and forelimb maximum retraction were all greatest for straight-line walk, the latter possibly indicating increased carpal flexion. Straight walk was measured on concrete, using an aisle to enhance straightness of the horse, while walk on the circle was measured on soft surface. Because of this, a surface effect may  be involved. Speed, stride duration and stride frequency may affect cannon ROM . Stride In the current study, there were several significant differences between inner and outer limbs, and inner and outer steps for midline variables. Without rider, a majority of the significant differences were related to the hindquarters. With rider, there were also several significant differences in the forehand variables. The outer hind limb had larger cannon ROM and maximum retraction angle, compared to the inner for both conditions. Outer hind maximum retraction occurs during the first part of the inner hind limb step. A larger retraction angle could indicate a larger longitudinal spread between the two hind limbs at this instant, explaining the lower S3 minimum, and larger S3 vertical ROM during the inner step, compared to the outer step. When ridden, the outer forelimb similarly had relatively larger cannon ROM. Along with this, withers vertical ROM was larger from outer forelimb midstance to inner forelimb midstance, compared to the other stride cycle half, and withers minimum position was deeper during early stance of the inner forelimb. These findings point towards a close coupling between limb spread and the vertical movement and minimum position of the croup (S3), and the same is suggested for the withers. Such coupling is predicted by the inverted pendulum model for the biomechanics of the walk .27.9% (28.5%) from inner hind limb to inner forelimb;19.7% (19.3%) inner forelimb > outer hind limb;31.1% (31.6%) outer hind limb > outer forelimb;21.3% (20.6%) outer forelimb > inner hind limb.Hind limb maximum protraction and maximum retraction both occurred earlier for the outer compared to the inner hind, and when ridden the outer forelimb reached maximum protraction relatively later. Timing differences between inner and outer limbs resulted in an asymmetry in durations between maximum protraction of sequential limbs, somewhat more pronounced with a rider compared to without. Using the results from ). Because these offset percentages are not the same for forelimbs and hind limbs, timing for protraction and retraction of the cannons will misrepresent the hoof-beat rhythm. The rhythm is expected to be relatively even four-beat in (equine) walk. Forelimb cannon maximum protraction and retraction occur approximately 2% before toe-on and 12% after toe-off, and hind limb cannon endpoints occur approximately 8% before toe-on and 8% before toe-off, based on 2001The timing of withers and S3 vertical excursions were also affected by the circle. S3 minimum position, which occurs during early hind limb stance, was relatively delayed for the inner step compared to the outer step, both with and without rider. This may relate to that the inner hind limb reached maximum protraction later, which would suggest that hoof landing was relatively delayed for the inner hind limb. Withers minimum was similarly delayed for the inner step vs the outer. The kinematics behind this is more difficult to deduct. Inner forelimb maximum protraction occurred relatively earlier, not later. It could not be approximated when the outer (or inner) forelimb was at its most retracted position, since the forelimb cannon will continue to retract as the carpal joint flexes. Maximum forelimb cannon retraction occurs at about 70% of the stride, which is in-between toe-off of the forelimb, at 64%, and maximum flexion of the carpal joint, at 76% of the stride .In Warmblood horses walking on a treadmill, a relatively lower withers minimum during early stance of one forelimb, compared to the other, was associated with left-right differences in stance duration and limb loading both with and without rider. However, while asymmetries in hind limb stance duration and hind limb second vertical force peak were associated with withers asymmetry without rider , when hoIn addition to decreased withers ROM, our IMU-data suggest that riding the horse on the circle disrupted the biphasic vertical motion pattern of the forehand (the withers)  and 3. TThere was only 10 horses and 5 riders. The horses were relatively small, with a maximal height of 158 cm, and included one pony. Data were evaluated from an experiment designed to mimic normal training sessions (except for adhering strictly to the 10 m circle). Since the riders rode almost without rein contact or using leg aids, the rider’s influence was essentially limited to the actual weight load, and the riders were of similar weight; the results are therefore less likely to be influenced by individual variation between riders. The equipment varied , includiThe outer forelimb had greater cannon ROM in ridden walk, as had the outer hind limb both with and without rider, compared to the inner limb. Larger croup vertical ROM during the inner step appears to be coupled to increased retraction of the outer hind limb. For walk on the circle, the presence of a rider mainly influenced the movements of the forehand: withers vertical ROM decreased and additional significant inner–outer differences appeared for withers and forelimb variables. Knowledge of the magnitudes and timing of the horse’s movements on the circle in unridden and ridden walk may stimulate riders to educate their eye and feel for the (correct) execution of circles. Such knowledge may also encourage further studies on walk kinematics, for example, how primary effects of circular movement interact with other factors such as active influence from the rider, natural horse asymmetries/sidedness, or lameness.10.7717/peerj.10354/supp-1Supplemental Information 1Click here for additional data file.10.7717/peerj.10354/supp-2Supplemental Information 2Numbers indicate the number of observations used in the analysis.Click here for additional data file.10.7717/peerj.10354/supp-3Supplemental Information 3Numbers indicate the number of observations used in the analysis. Data from one horse-rider combination is missing because of failure of synchronization of S1 sensor.Click here for additional data file.10.7717/peerj.10354/supp-4Supplemental Information 4Numbers indicate the number of observations used in the analysis. In this illustration the timing of straight limbs contains two events, hence the wide boxes.Click here for additional data file.


Introduction: To establish a pilot study on applying two low dose (40 h) constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy (CP) after botulinum toxin (BoNT-A) injection during preschool education.Methods: Five children with spastic CP  undergoing regular BoNT-A injections and rehabilitation programs were included. Participants were randomly allocated to one of two CIMT programs (40 h): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection. The outcomes were measured by changes in Goal Attainment Scaling (GAS), the grasp and Visual-Motor Integration (VMI) test in Peabody-Developmental Motor Scales (PDMS), the self-care scale on the Functional Skill Scale, and the Caregiver Assistance in Chinese Version of Pediatric Evaluation of Disability Inventory (PEDI-C), Anxiety and Oppositional Defiance Problems of Achenbach System of Empirically-Based Assessment before and after the CIMT interventions, and at every 2 months' follow-up thereafter.Results: The mean age of the participants was 5.31 years, BMI was 16.7 (kg/m2), VIQ was 86.4 ± 8.5, and dose of BoNT-A injection in the upper limb was 42 ± 26.6 units. Grasp, VMI, and self-care on the Functional Skill Scale were significantly better in the 4-week 2-hours/day CIMT program . GAS, grasp, VMI, two 2 self-care scales of PEDI were significantly improved after the CIMT programs, and improvement continued for up to 4 months after the programs. There was no clinical evidence showing changes in the scores for anxiety and oppositional defiance problems during the study period.Conclusions: The preliminary findings, although limited, suggest a potential therapeutic role for the school-based CIMT program after BoNT-A injection. The 4-week 2-hours/day CIMT program might be better than a 2-week 4-hours/day program in terms of self-care and hand function when performed in kindergarten in this pilot study. Furthermore, this pilot study provides valuable information; therefore, it is crucial to include more CP children and blinded assessors for hand function and ADL in the future study. Cerebral palsy (CP) is the most common physical disability in childhood, and 39% of children with CP have hemiplegia –3. HemipChild-active approaches, for example, goal-directed training in hand function tasks , that are designed to meet a goal meaningful to the child , are conThis study was designed to be a pilot study employed for 4-week 2-hours/day and 2-week 4-hours/day CIMT (40 h) interventions in children with hemiplegic CP after a BoNT-A injection during preschool education, and to compare the effects and psychological stress of CP children relative to the two CIMT programs. The main hypothesis was that a low-dosage school-based CIMT (40 h) program could be performed smoothly in preschool and produce benefits in hand function and activities of daily living (ADL). The second hypothesis was that 2-week 4-hours/day CIMT would produce significantly greater benefits than 4-week 2-hours/day CIMT and less psychological stress.This study used a randomized crossover design with a “wash-out” period, and was conducted from June 2014 to December 2016. The study was approved, and ethical clearance was obtained from the hospital Institutional Review Board (IRB 130210). All participants and their parents provided written informed consent for participation.Children with hemiplegic or quadriplegic spastic CP who were in a regular rehabilitation program with BoNT-A injections were invited to participate in this study. The enrolled children were classified as Gross Motor Function Classification System level I or II, were aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was >10°. Children were excluded if they: (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist. Based on a repeated ANOVA comparison of changes using an effect size of −0.8 for both groups, a significance  level of 0.05, and 80% power, we required six children for this pilot study.Participants were randomized using a computerized random number and crossover-allocated to two different CIMT programs: one was a 2-week 4-hours/day program, and the other a 4-week 2-hours/day constraint program in preschool education.After at least a 7-month “washout period,” the children were crossed over to another CIMT program . The CIMThe outcomes were measured by any change in two playing goals and two self-care goals of the GAS, grasp, and visual-motor integration (VMI) in the Peabody-Developmental Motor Scales II (PDMS II), 73 functional skills and eight caregiver assistance self-care scales in the Chinese Version of the Pediatric Evaluation of Disability Inventory (PEDI-C), and anxiety and oppositional defiance problems in the Caregiver-Teacher Report Form (C-TRF)-Diagnostic and Statistical Manual (DSM)-oriented scales of the Achenbach System of Empirically-Based Assessment (ASEBA). Measurements were taken just before the BoNT-A injection (T0), 1 month after the injection (T1), shortly after the CIMT intervention (T2), and at 2 months (T3) and 4 months (T4) after CIMT. The measurements of PDMS II and GAS were performed by the child's occupational therapists, the PEDI-C records were maintained by the child's caregivers, and the C-TRF measurements were performed by the child's caregivers and school teachers. The measurements could not be blinded because the assessors  had to know the programs and how to operate them.GAS included two playing goals and two self-care goals. The goals were decided by the occupational therapist, the preschool teachers, and the main caregiver. The goals were weighted by applying the factor of importance × difficulty, where importance of the goal to the patient was graded as 1 = fairly important, 2 = very important, and 3 = extremely important. Difficulty of achieving the goal was rated as 1 = probable, 2 = possible, and 3 = doubtful. Baseline scores were allocated as −1, if the goal was achieved as predicted, then scored 0 when evaluated at 2 and 4 months after CIMT. Achievement above the level predicted was scored at +1 (“somewhat better than expected”) or +2 (“much better than expected”). No change or achievement below the expected level was scored as −1, and a worsening of the target function was scored as −2. GAS was calculated for the aggregated score of each patient's goals by applying the formula recommended by Kiresuk and Sherman .The fine motor skills of the affected upper limb were evaluated using the grasping and VMI scores of the PDMS II. These scores can gauge improvement after the CIMT program. The C-TRF (1.5–5) DSM-oriented scales of the ASEBA can assess the children's behavioral/emotional problems from the perspectives of multiple informants . The anxThe Wechsler Preschool and Primary Scale of Intelligence-Revision-Chinese-language version  is used T-test.Descriptive statistics  were used for demographic and clinical/treatment factors of interest. Comparisons of the two CIMT programs and the different times were carried out using Generalized Estimating Equations. Differences in the C-TRF-DSM scores between the caregivers and teachers were analyzed by Paired Samples p < 0.05 was considered statistically significant.All analyses were performed using SPSS software version 22.0 for Windows . A 2)  , VIQ was2) . The brap < 0.001). The GAS especially showed progressive improvement after the CIMT programs (p = 0.856) in the GAS between two 2 CIMT programs.The GAS for the two playing goals and two self-care goals was significantly improved after the CIMT programs, and continued to improve until 4 months after CIMT  .The grasp  and VMI = 0.001) . The grap < 0.001, p = 0.153, In terms of ADL, the self-care functional skill score  of the Pp < 0.001, p < 0.001) program, but the caregivers reported more stress in the 2-week 4-hours/day CIMT program . The anxiety and oppositional defiant disorder problems reported by the teachers were the highest shortly after CIMT, then gradually improved. In the caregiver's report, anxiety was in the subclinical range during T1 and T3, and oppositional defiant disorder was the highest during T2, then gradually improved .The anxiety and oppositional defiant disorder did not achieve clinical significance during the study period. Of interest, the anxiety and oppositional defiant disorder scores reported by the teachers were higher in the 4-week 2-hours/day CIMT  program . EliassoOverall, there was no significant clinical evidence in the scores for anxiety and oppositional defiant problems. This indicated our treatment programs administered in school did not aggravate the children's stress levels in the long run, as in Lin's study . The scoThe novel finding of our study is that the low-level CIMT program could be performed smoothly by school teachers. Furthermore, the evaluation is multidisciplinary, including not only therapists, but also teachers and caregivers. Most CIMT studies were performed at home  or in thOur research had several strengths. First, we used a cross-over study design and long wash-out period, which could eliminate the bias of the children's personal and environmental differences, and the residual effect of the last BoNT-A injection. In this way, the children could maintain their regular BoNT-A injection and usual rehabilitation programs, but it would take longer (at least 1 year) to finish the program than in other studies , 25, 28.d is determined by calculating the mean difference between two CIMT programs to determine the effect size of 0.34. Then, using a repeated ANOVA comparison of change with an effect size of 0.34 for both groups, three measurements, a significance  level of 0.05, and 80% power, 16 children would be required in a future study.This pilot study could be used in larger clinical studies. Cohen's This study has several limitations. First, the small sample size might limit the power and generalizability of the results to the population of children with CP. Second, we did not use a blinded study design. Therefore, there might be some measurement bias. In a further study with a larger sample size, blinded measurements of PDMS and a measure for spasticity are suggested.The results of this pilot study reveal a high rate of completion and adherence in the school-based CIMT program. The preliminary findings, although limited, also suggest a potential therapeutic role for the school-based CIMT program after BoNT-A injection. The 4-week 2-hours/day CIMT program seemed to be better than a 2-week 4-hours/day program in terms of self-care and hand function when performed in kindergarten in this pilot study. However, we must be attentive to the discomfort and emotional stress of the children when using the CIMT program. This pilot study provides valuable information; therefore, it is crucial to include more CP children and a blinded assessor for hand function and ADL in future studies.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Institutional Review Board, Changhua Christian Hospital, IRB approval # 130210. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin.C-LW, S-FL, and C-HL contributed to the study design. C-LW, C-HL, Y-TH, and Y-RL participated in data collection and analysis/interpretation. C-LW and S-FL participated in manuscript preparation. All authors revised and commented on the manuscript. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


A growing body of evidence suggests that early life health and developmental outcomes can be improved through parental support programs. The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted “Reach Up and Learn” program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.A randomized, stepped-wedge design was used to roll out and evaluate the two parenting platforms in Boa Vista municipality. A total of 39 neighborhoods with a high Neighborhood Vulnerability Index were selected for the study. For the first phase of the program, nine neighborhoods were randomly selected for home visits, and two were randomly selected for the center-based parenting groups. In the second phase of the program, 10 neighborhoods were added to the home-visiting program, and eight were added to the center-based program. In the final phase of the program, the remaining 10 control areas will also be assigned to treatment. Study eligibility will be assessed through a baseline survey completed by all pregnant women in the 39 study areas. Pregnant women will be eligible to participate in the study if they are either classified as poor, were under age 20 years when they became pregnant, or if they indicate to have been exposed to domestic or sexual violence. To assess program impact, an endline survey will be conducted when children reach age 2 years. The primary study outcome is child development at age 2 years as measured by the PRIDI instrument. Secondary outcome will be infant mortality, which will be assessed linking municipal vital registration systems to the program rollout.This trial will assess the feasibility and impact of parenting programs rolled out at medium scale. The results from the trial should create evidence urgently needed for guiding Brazil’s national Criança Feliz program as well as similar efforts in other countries.NCT03386747. Registered on 13 December 2017. All items of the World Health Organization Trial Registration Data Set are available in this record.ClinicalTrials.gov, ID:  Brazil has made remarkable progress with respect to child nutrition and child survival over the past decade, with particularly impressive results in large urban areas. Infant mortality has dropped by roughly 50% since 2000 to 14 deaths per 1000 births across the country . From a Care for Child Development (CCD) framework, Jamaica’s Reach Up and Learn program, Early Head Start in the USA and the UK’s Sure Start [Parental programs to promote nurturing environments have been successfully implemented in a range of low- and middle-income countries, including UNICEF’s re Start , 18–22.Brazil has successfully implemented its “family health strategy” – a health-focused home-visiting program coordinated by primary care units – since 2006 –25. In 2In this project, we assess the scalability of a locally adapted version of an early childhood program previously developed in Jamaica. Between 2014 and 2016, the Jamaican “Reach Up and Learn” curriculum was adapted to the Brazilian context and tested through a small randomized trial in São Paulo . The content, delivered through fortnightly home visits, comprises parenting-skill tips as well as child stimulation activities supported with basic toys, addressing motor, social emotional, and cognitive development and language for families with children aged from 9 to 36 months.While the reach of this program was not universal in this original trial, the estimated impact on participating mothers was large, and the program was well received at the local level (manuscript with main results under review). While this curriculum was delivered through home visits in the original study in São Paulo, recent evidence from Bangladesh  suggestsGiven this and given also that the municipality had previously invested in a center-based model, it was decided to test both delivery platforms within this project. Given the relatively high burden of neonatal mortality in the study area, we also decided to start the intervention earlier. By enrolling pregnant women at the beginning of their third trimester, the revised intervention program aims to improve support for mothers during the antenatal and neonatal periods with the ambition to increase health service utilization and reduce the risk of adverse birth outcomes. Figure The objective of this study is to rigorously assess the impact of an extended version of the previously tested and validated parenting curriculum on child survival and development in Boa Vista municipality. Through a three-arm trial, we will assess home visits through child development agents (intervention 1) as well as center-based parenting groups (intervention 2) relative to a randomly selected control group. Through a stepped-wedge rollout approximately one third of communities will receive the intervention in phase 1 of the rollout; in phase 2 of the program, two thirds of communities will be selected for interventions. All areas will receive interventions in the last phase of the program.To evaluate the effect of home- and center-based parenting programs on child survival and developmentTo assess the impact of both programs on parenting behavior and practicesTo evaluate the implementation processTo estimate program cost and cost-effectivenessTo assess relative program, reach among extremely poor and immigrant populationsTo assess program spillover on older siblings in the householdThe specific study objectives are:The study was designed as a stepped-wedge, cluster randomized controlled trial with three arms. Arm 1 represents intervention delivered through fortnightly home visits; Arm 2 consists of the same content delivered through fortnightly center-based group meetings; Arm 3 is the control group.To avoid contamination, neighborhoods were used as units of randomization. All 53 neighborhoods in Boa Vista were classified according to the municipality vulnerability criteria. Only neighborhoods classified as B (medium vulnerability) and C (high vulnerability) will be targeted by the program. As of 2017, 42 neighborhoods were in this category.Three neighborhoods had either existing home-visiting programs or other planned interventions, and were excluded from the study, leaving a final study sample of 39 neighborhoods. Figure Survive and Thrive in Brazil – The Boa Vista Early Childhood Program eventually aims at providing support to all children born in the municipality of Boa Vista from the end of the second trimester of pregnancy until the children reach age 3 years. This program was designed to closely align with the national “Criança Feliz” program  [From a programmatic perspective, the 57/2016) , which wThe city of Boa Vista has a population of approximately 330,000 people, with, 22,377 families (~ 30%) currently receiving or enrolled in social cash transfers under the Bolsa Familia Program, very similar to the national average (35% of the population) . AccordiStudy eligibility is restricted both spatially and at the individual level. As mentioned in the “Study design” section, the scale-up targets only vulnerable neighborhoods. Boa Vista social services classify all neighborhoods based on literacy rates, average per capita income (less than one quarter of the minimum wage), access to water, sanitation, sewage systems, and electricity into A (low vulnerability), B (medium vulnerability), and C (high vulnerability) areas. Out of the 55 neighborhoods in Boa Vista, 12 were classified as “high socioeconomic status” (A), 14 were classified as “low vulnerability” (B), and 29 were classified as “high vulnerability” (C). The study was restricted to the 43 B and C areasWithin all target areas, all pregnant women as well as women with children under the age of 1 year are eligible for the program as long as they are either poor, were under the age of 20 years at the time of conception or were ever exposed to domestic or sexual violence.The intervention will be delivered during fortnightly home visits with the presence of the child and at least one of the main caregivers . The home-visiting curriculum is divided into three main modules: (1) the pregnancy module: this module is designed to make mothers aware of pregnancy danger signs, to encourage adherence to antenatal care , to improve bonding and positive parental practices and to prepare women for breastfeeding; (2) the neonatal module: comprises three home visits during the baby’s first month of life. One visit during the first week, a second visit at 15 days and the third visit at 28 days. The primary focus of these visits is babies’ health, breastfeeding and bonding; and (3) the child module for ages 2–36 months. Each home visit has three or four play activities to address child development domains . A recycled-materials toy kit is used to support these activities. Visits take in average 45 min; after demonstrating and practicing each activity with the caregiver, the visitor leaves the toys, and mother/caregiver is encouraged to play and interact with the child in the 2-week interval between the visits. Activities are age-appropriate, and toys and learning materials are exchanged for a new set at each visit. Home visits will be conducted by newly hired and trained child development agents, who will be tasked to complete 60 home visits per month (three visits per workday), supporting 30 families.Group meetings are designed to deliver essentially the same content. Meetings are held fortnightly at the CRAS center  for groups of eight mothers and their children, other members of the family can participate as well. Groups are formed with participants at a similar stage of gestation or with children of similar age. Group composition remains fixed to increase bonding over time. The only difference between the center and the home-based curricula is the number of activities per session: due to the larger number of participants, the number of activities is reduced to two at the centers. The neonatal module is also reduced to one or two sessions since we do not expect mothers to attend the sessions during the first 2 weeks of the babies’ lives. Group moderators will be hired by the project and will be tasked to schedule three age-group-specific 1-h and 30-min sessions each day.Program teams will be based at the seven regional social service units (CRAS) and will deliver the intervention according to the services’ coverage area. Group meetings will be held at the centers, where a meeting room will be fully dedicated to the project for ease of access to mothers since the rooms are distributed within the more vulnerable areas.Attendance at the sessions, dropouts and refusals will be registered in the intervention logs and monitored by the team on a monthly basis. In order to improve adherence, if a participant skips three consecutive sessions, she will be contacted by the delivery team supervisor to understand the reasons and eventual problems that need to be addressed to continue participation. The dropout log registers the participants’ motives for discontinuity and, depending on these, the supervisor can also contact the participant to revert dropout.Pregnant women living in the control-group-allocated neighborhoods will receive the regular public services provided by the municipality. In terms of health care, they will receive primary, secondary and tertiary care through the primary care units and hospitals run by the municipality or state secretariat. They will also have access to the regular social services provided by the Social Services Units and to other social (and cash transfer) programs such as the Bolsa Família.After the trials have started, there will be no special criteria for discontinuing or modifying the allocated interventions. The research group will monitor, on a monthly basis, protocol-adherence aspects such as group allocation, participation, logs, and other registry instruments and will participate in the weekly delivery team meetings and supervise home visits and group meetings.No protocol amendments are expected during the trial but the private investigator (PI) will notify funders, the municipality and the Institutional Review Board (IRB) if any changes should be needed. Any deviations from the protocol will be documented using a breach report form and the protocol will be updated in the clinical trial registry.Program rollout will be closely monitored by the Steering Committee. Before the trial launch, the municipality agreed not to deliver similar concomitant interventions for this population in the selected neighborhoods. To ensure that this will not happen in practice, the research group will collect information on other social program participation.Implementing the strategies of the ECD intervention (groups meeting and home-visiting) will not require alteration to usual care pathways (including use of any medication). Standard medical and child support care will be available to all study arms throughout the trial. There is no anticipated harm and compensation for trial participation during or after the trial. All participants will continue to have regular access to public health and social services once the trial is over. The continuity of the intervention after the trial is dependent on mayoral discretion.The primary study outcome is child development at age 2 years as assessed by the PRIDI Scale. The secondary study outcome is child survival, which will be assessed using data from the municipality’s vital registration system (SIM and SINASC). Maternal depression will be assessed using the Center for Epidemiologic Studies Depression Scale .Intention-to-treat analysis will be used to compare outcomes across the three study arms.Additional per-protocol analysis will be conducted using data on program compliance. Our primary measure of compliance in the home-visiting arm will be the number of home visits completed. Our primary compliance measure in the center-based groups will be the number of sessions attended by the mother. Table Randomization of program rollout timing was based on a simple random-number draw in Stata. The number of treated areas in phases 1 and 2 was determined based on logistical feasibility and an initial agreement between the municipality and the project team: in phase 1, nine areas were chosen for home visits and two for center-based programs. In phases 2 and 3, program reach was gradually increased to reach all communities as outlined in the “Study design” section above. In phase 1, 11 neighborhoods will receive the intervention; in phase 2, 27; in phase 3, all B and C neighborhoods will receive the interventions. Figure Household classified as poorPregnant women under age 20 years (teenage pregnancies)Women with previous exposure to partner violenceRecruitment for this project will be implemented in close collaboration with the Municipality Secretariat for Social Wellbeing and Health (SSWH). The SSWH identifies eligible pregnant women each month, and links them to the project team. Each woman is then visited by study staff and, conditional on their consent, completes a baseline interview. According to the municipality of Boa Vista, there are approximately 600 new pregnancies per month. The baseline forms are then used to establish eligibility for the program. As stated above, the following three  groups of women are eligible for the program:In the first few years of the program, a small sample of women with children under age 1 year will also be enrolled. This sample will be used to assess the relative impact of reduced exposure to the interventions.In order to achieve enrollment to reach the sample size, the research group hired and trained a team of interviewers that will visit the eligible participants from the municipality list, but also actively search for other potential participants in the field. The research team will use the municipality official birth records on a monthly basis to monitor any unenrolled new children born in the catchment areas and enroll them afterwards.Given that we will have 12,000 participating households in the intervention, we do not foresee any difficulties reaching the 3000 sample-size target for the endline.Given the nature of the intervention, blinding of participants is not possible. Endline interviewers will be blind to group assignment.Given that the intervention does not present a risk for the population and that the municipality has committed to delivering interventions following the established timeline, there are no formal stopping rules for this trial. We also do not foresee needing any interim analysis for such purposes. However, even if not related to the intervention, the home visitor or group facilitator reports, or is informed of, any adverse event such as domestic violence, or health risk, which will be reported to the supervisor and to the Social Service Unit manager and relevant regulatory bodies as required, indicating expectedness, seriousness, severity, and causality.Based on the estimated number of births in the targeted B and C areas, we anticipate completing approximately 12,000 baselines (screening interviews) over the project period. Out of these mother-child dyads, we will randomly select 3000 for the endline assessment. We assume an average causal effect of 0.5 standard deviations (SD) for compliant mothers. With an anticipated average compliance rate of 50%, the study is powered to detect an intention-to-treat effect of 0.25 SD with power 0.9 between each of the two intervention arms and the control arm, assuming an average sample of 120 households in each of the 11 neighborhoods treated in phase 1, and an average sample of 60 households in each of the 28 control neighborhoods, assuming an intra-class correlation of 0.02.In order to assess spillovers within households, we will also assess all older siblings under age 4 years in households selected for endline. Based on the high fertility rates observed at baseline, we anticipate a sample of 750 older siblings. Assuming a uniform distribution of siblings across clusters, the study is powered to detect a 0.3-SD change in PRIDI score with power 0.8.In order to assess domain-specific changes in children’s development, we will also invite 80 mothers from each arm for a detailed assessment using Bayley’s Scales for Infant and Toddler Development (BSID-III). For these assessments, we will randomly select mothers from the control group as well as compliant mothers from the two intervention arms.Baseline survey collection started on 1 December 2017 and will be finished by July 2020. The home-visits team was trained in November 2017 and visits were launched shortly after initiation of baseline in the phase-1 home-visiting areas; the first births within this group occurred in February 2018. Due to logistical challenges, center-based programs were started later; the two areas randomly selected for phase 1 of the project were formally launched in July 2018. Phase 2 (both for home visits and center-based programs) was started in July 2019, with 10 neighborhoods added to the home-visiting programs, and eight added to the center-based programs.Endline surveys are scheduled to start in April 2020 and will target children at age 2 years. With the targeted sample size of 3000 households we anticipate to complete endline by July 2021. BSID-III assessments will start in July 2020 and should be completed within 6 months.Baseline and endline data will be collected in electronic format on tablets and stored on a secure server. The project leader will be responsible for the anonymization of the data system. A unique identifier will be used in the data system to preserve participant privacy and confidentiality.For statistical analysis, standard regression models will be used for the continuous PRIDI outcome. Logistic regression models will be used for the secondary outcome of child mortality. All analysis will be conducted using the Stata 15 statistical software package. Primary analysis will be intention-to-treat. To assess the impact of partial compliance, we will also estimate average treatment effects on the treated .The study was approved by the researcher’s IRB under protocol number CAAE:73722917.4.0000.0076 in August 2017.Each participant signs the consent form at enrollment, during the baseline interview visit. Should the participant be a minor, the consent form is signed by a legal representative. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage.The consent form is signed in two copies so that the participants can keep a copy of the signed consent form. The PI’s, the social services’ responsible and the IRB’s contact information are provided in the consent form so that participants can find these in case of questions or other issues. Copies of the consent form are available from the corresponding author on request.As of November 2019, trial enrollment is open and is scheduled to continue until July 2020. The present protocol is in its first version and has been since November 2017.A large body of evidence has highlighted the importance of early parenting and nurturing care on child development. However, equitable early childhood programs and public policies are crucial for ensuring continued progress in Brazil’s efforts as well as other international efforts , 29–31.


Integrated care is regarded as a key for care delivery to persons with chronic long-term conditions such as Parkinson’s disease. For persons with Parkinson’s disease, obtaining self-management support is a top priority in the context of integrated care. Self-management is regarded as a crucial competence in chronic diseases since the affected persons and their caregivers inevitably take up the main responsibility when it comes to day-to-day management. Formal self-management education programs with the focus on behavioral skills relevant to the induction and maintenance of behavioral change have been implemented as a standard in many chronic long-term conditions. However, besides the example of the Swedish National Parkinson School, the offers for persons with Parkinson’s disease remain fragmented and limited in availability. Today, no such program is implemented as a nationwide standard in Germany. This paper provides (1) a systematic review on structured self-management education programs specifically designed or adopted for persons with Parkinson’s disease, (2) presents the Swedish National Parkinson School as an example for a successfully implemented nationwide program and (3) presents a concept for the design, evaluation and long-term implementation of a future-orientated self-management education program for persons with Parkinson’s disease in Germany. Integrated care concepts (ICCs) are a core strategy to meet the health care challenge of age-related chronic degenerative diseases like Parkinson’s disease (PD) . Common PD is a prime example of a disease that confronts affected persons with high and evolving challenges in taking up this decade-long task: persons with Parkinson’s disease (PwPDs) experience an increasingly complex disease burden with an array of motor and non-motor symptoms, require a multidimensional pharmaceutical and non-pharmaceutical treatment regimen and experience a varying therapeutic effectiveness along the disease course.Self-management is defined as “tasks that individuals must undertake to live with one or more chronic conditions. These tasks include having the confidence to deal with (1) medical management, (2) role management and (3) emotional management of their conditions” . A recenSelf-management stretches beyond medical management such as taking the prescribed medication and requires the ability to adopt one’s behavior to symptoms or disability and to cope productively with emotions like fear or anxiety. This means that self-management represents a complex cognitive-behavioral challenge, involving the constant adjustment of role-related behaviors and processing of disease-related emotions. Negative emotions such as anxiety are related to lower quality of life (QoL) and higher mortality in PD ; this unThis explains why unidimensional education initiatives, e.g., solely promoting disease-related knowledge or focusing on isolated behaviors like compliance often failed to be effective . Rather,The program is based on a person-centered conceptual framework related to social cognitive theory . The theEven though self-management interventions have been shown to be effective in a variety of settings  and with varying delivery strategies  , there iThe CDSMP is a prime example of such a program, delivered to small groups of PwCDs and care givers in several modules over several weeks. The program can be provided by trained health care providers (train-the-trainer principle) and has been shown to be generalizable to different diseases and cultural settings ,17. SuchIn spite of PD being a prime example of a progressive long-term condition with high demands in self-management competence, access to structured SME programs for PwPDs has lacked behind other comparable diseases. The current work will provide (1) a systematic literature review about structured self-management programs for PwPDs, (2) report the successful nationwide implementation of the National Parkinson School (NPS) in Sweden and (3) present a concept for the design, evaluation and sustainable implementation of a possible future-orientated SME program for PwPDs in Germany.A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria with the objective to report content, format and outcome of different SME programs specifically designed or adopted for PwPDs . Level oLiterature research was conducted between May-June 2020 using the databases PubMed and EBSCO , American Psychological Association (APA) PsycArticles, APA PsycInfo, Table of Contents (TOC) Premier). No publication date restriction was applied. Search term was: (parkinson*) AND ((“patient education”) OR (“patient school”) OR (“self-management”) OR (“self management”) OR (“selfmanagement”)).Eligibility criteria for the studies retrieved by the search terms were: (1) inclusion of elements/components specifically dedicated to training of principles/skills/beliefs needed for induction or maintenance of behavioral change (self-management approach); (2) Program either adopted of specifically designed for PwPDs. Exclusion criteria were: (1) posters, books; (2) unidimensional programs: no program elements identifiable specifically dedicated to principles/skills/beliefs needed for behavioral change next to other training elements ; (3) full text not accessible.Included studies are presented in separate tables for quantitative and qualitative evaluation studies. Protocols for future planned studies to evaluate SME programs are given in another separate table. For the PRISMA flow diagram checklist, please refer to After removal of duplicates, 631 records were retrieved, of which 551 were excluded after screening of title and abstracts for in-/exclusion criteria. After full-text assessment of the remaining 62 articles, 23 fully met inclusion criteria and were integrated into this systematic review; 20 described the evaluation of self-management interventions at different stages of implementation, and 3 described evaluation protocols of planned studies on future programs. One additional study was included that was not retrieved by the search terms but that otherwise met all inclusion criteria [A total of 18 different programs were described in the 23 publications. All programs were organized in modular small group sessions (2–18 sessions) with peer PwPDs, 8 programs 35%) including caregivers ,26,27,28% includiWith the exception of two programs ,33, all Both qualitative  ,27,38 anOf the quantitative studies, 3 reached level I according to AACPDM study quality scoring ,39,44, 3Evaluation timepoints were at baseline and immediately or with little delay after the last element of respective intervention, and in 6 (26%) at varying intervals (2–12 months) after the intervention ended to assess for sustained effects ,32,34,40Reported primary or secondary outcomes and employed measurement instruments fell into all domains of health-related outcomes , rangingThe 5 most often reported outcomes were: Health related and general quality of life  ,42,43,44Although all studies reported various baseline characteristics and other contextual variables , statements about possible predictors, mediators or confounders were reported in 4 studies only ,34,36,39There was only one program  evaluated in transcultural multicenter studies in seven European countries . One addThere were 3 qualitative studies, all with the purpose of formative evaluation ,27,38. 8Although only some of studies stated the primary outcome clearly or the study power  has its origin in the “Person Education for PwPDs and their carers” (PEPP), developed by the European EduPark consortium in 2002 . The SweThe PEPP is focusing on strategies to manage the psychological and social impact of the disease and the main goal is to empower participants to better deal with the challenges brought on by PD, primarily focusing on the psychological and social impact of the disease . This isApproximately 20–30 groups undergo the NPS in clinical care in Sweden each year. The program has until now mainly been provided at neurological and geriatric clinics connected to the larger hospitals, which is due to the allocation of resources in the Swedish health care system. With improved and widespread technology like easy and available apps for video conferences, new ways of providing the NPS also to persons living in more remote areas are under development. Recent research shows that the NPS is considered valuable for the participants and contributes to enhanced adaptation and acceptance of life with PD as well as techniques for self-knowledge to manage symptoms of disease in everyday life. The dyadic approach was viewed as a shared platform of knowledge and understanding and the small group format exchanging experiences and feeling support from others in the same situation was highly appreciated . After aGiven the high importance of self-management for PwPDs and given the sometimes decade-long nationwide availability of certified SME programs for persons with similar diseases in Germany, PwPDs should have the same opportunity to benefit from the general availability of such a structured, evidence-based and quality-controlled program. In order for this to become reality, the same level of professional effort is needed that enabled the nationwide availability of programs for other comparable diseases.In spite of the evidence for efficacy/effectiveness for a variety of existing programs for PwPDs worldwide, the effects were comparably small, not always reproducible and exposed to an important attrition effect often already 6-months post intervention  above. AHowever, existing programs should rather be understood as a valuable source of inspiration then as a ready-made solution that simply needs to be implemented broadly. Most concepts have never achieved the stage of broad sustainable implementation, or in the case of the PEPP were developed 18 years ago. It is very unlikely that a program developed in 2002 still provides the optimal answer to needs, expectations and best implementation strategies in the context of rapidly evolving living conditions and a disruptive digital transformation process taking place.Any novel and future-orientated program can profit from the knowledge and experience generated through the various existing programs, but equally requires innovations concerning content, delivery concept including possible digital components, concerning a meaningful evaluation concept and to meet the regulatory requirements for a nationwide certification.In the following sections, conceptual considerations about possible areas of improvement for a future-orientated and sustainable SME program are given. In addition, a sequential implementation concept is presented, consisting of 4 phases from a structured needs assessment of both PwPDs and experts to the final step of obtaining certification as the basis for nationwide implementation in Germany.One potential shortcoming is that there is no concept for a disease-stage adopted program. It is unclear when PwPDs are to be educated, whether this education should be repeated over the decade-long disease course, and if so, how much of the program needs to be adopted to possibly target several subpopulations. As described, in Canada such disease-stage-specific SME programs have been implemented, consisting of three subprograms: an early program for general disease management (EMP), an intermediate program for safe mobility (SMP), and a late-stage program for fall prevention (FPP) . So far,However, theoretical considerations about the varying requirements in self-management over the course of chronic diseases argue for this approach. In diseases like PD, both symptom load and treatment responsiveness vary strongly with time ,55. A coPwPDs can be expected to wander along this “pyramid” during their disease course: In the honeymoon phase therapeutic needs are of lower complexity and the relative contribution of person self-management to overall disease management can be expected to be high ,58. In iAnother argument for a stage-specific program design is the importance of modeling and social persuasion for successful self-management interventions . The betA third argument for stage-specific program is that cognitive capacities are inflicted along the disease course, with nearly all PwPDs to be expected to become demented in advanced disease stages . Since aThe PEPP has a strong strategic focus on the CBT-based self-management intervention and dedicates the majority of the program to teaching behavioral skills such as action planning, self-reflection, reframing, self-efficacy beliefs or relaxation techniques . RelativThe effects of all SME programs are exposed to attrition . Even ifIn addition, any future program needs to be cost-effective to achieve financing agreements with statutory health insurers as the only realistic long-term financer in Germany. Continuous disease-accompanying SME will most likely neither be feasible nor financeable. Therefore, complementing SME with a digital and possibly long-term follow-up intervention appears as the only realistic option to promote more sustainable effects than with the current and mostly purely analogue programs.The potential of a possible digital extension is illustrated by the growing body of evidence for the effectiveness of online behavioral cognitive therapy, including for elderly PwCDs . In addiIf the goal of any future SME program is to assure equal access, than a digitalized automated program element is likely the most effective measure to achieve this.Many of the preceding programs combined SME with other therapeutic interventions, such as physiotherapy or occupational therapy. It is unclear whether SME programs are more or less effective when combined with other interventions, in spite of single studies addressing this question .However, such a combination appears as a promising concept: If self-management relies on the mastery of skills needed for induction and maintenance of health-promoting behavioral change and if domain-specific training (modeling) of these skills is an important strategy ,17, thenAs mentioned, in a majority of studies distal complex outcomes such as QoL have been reported as primary outcome, although only an indirect effect through mediators and/or more proximal outcomes can be postulated. This provides one possible explanation for the often small effects in combination with relatively rapid effects attrition.The importance of a careful study design has been recently illustrated by a recent Swedish quasi-experimental case-control study on the NPS . AlthougIn order to avoid the sole reliance on distal complex outcomes such as QoL, exposed to a multitude of effects besides the SME program to be evaluated, evaluation concepts should consider the theoretical basis of SME programs. As mentioned, the starting point of numerous SME programs is the Chronic Disease Self-Management Program (CDSMP) that is based on Bandura’s theory of behavioral change, validated in numerous studies not only on health-related, but also on general behaviors ,62. Only(1)Phase 1: Systematic needs assessment of PwPDs and caregivers in combination with an expert-based consensus about contents, delivery concepts and program objectives;(2)Phase 2: Development of an SME program in an dynamic co-design process, including formative evaluation;(3)Phase 3: Proof of efficacy and proof of effectiveness in a multicenter setting, representative of the later application context;(4)Phase 4: Obtain certification and agreement of funding with statutory health insurers.To address the above mentioned issues and to achieve the goal of a nationwide certified PwPD SME program, the following sequential phases are suggested :(1)PhaseAs a first step, the needs of both PwPDs and their caregivers are to be systematically analyzed . Both grTo understand expected disease-stage specific needs from the beginning of the process, four different person subgroups are to be assessed separately for their specific needs in a structured format, e.g., focus groups: (1) de-novo PwPDs (defined by time since diagnosis ≤12 months); (2) early onset PwPDs (≤50 years); (3) general early to mid-stage PwPDs , and (4) PwPDs with advanced disease stages  to assist more than 100 statutory health insurances in Germany in the evaluation of SME programs . The maiThe German Social Insurance Code (SGB V) regulates the legal basis for the promotion and implementation of SME programs for persons with chronic long-term conditions.Before approving a specific SME program, an insurer has to inspect the evidence for effectiveness. Expert opinion can be requested from the “Medizinischer Dienst der Krankenkassen (MDK)”, a service unit developed jointly by the statutory health insurances to control medical care processes. To be formally assessed, information has to be submitted on the structure and content of the program together with information about its effectiveness, local facilities and proof of qualification of the interdisciplinary educational team  Table 4Table 4. Applicants receive a non-negotiable approval or refusal note. Approval comes with a valid certificate, but the specific reimbursement still has to be negotiated with each of the statutory health insurers separately. Even though this process is heavily regulated, strengths are the standardized and transparent requirements, offering equal chances to all applicants.Reimbursement can be granted if the insured person recently received medical treatment for a specific disease or is currently proceeding such a treatment and if the participation rate was >80% . CaregivDespite the numerous arguments for a structured SME program for PwPDs and despite the fact that persons with similar chronic diseases  have access to such programs as part of the regular catalogue of benefits of statutory health insurers, so far this could not be achieved for PwPDs in Germany. To our knowledge, The NPS in Sweden is the only example of nationwide coverage with an SME program for PwPDs.However, there are many arguments why this should not be the exception but the norm. It is widely accepted that integrated care concepts should be person-centered ,69. TherPerson-centered care considers the needs of all persons involved in a care relationship—be it the patient, informal or formal healthcare providers—to be of equal importance . SME is As mentioned, there are only few reported studies on temporary regional efforts in structured SME for PwPDs in Germany ,40,42,51Leaving self-management support to the discretion and personal capacities of individual healthcare providers is not compatible with the ambition to offer more equal, timely and better quality care through structured integrated care concepts. Whereas some components of integrated care concepts need to be tailored to the specific regional implementation context, SME programs do not belong to these. Rather, basic principles and assumptions have been repetitively shown to be valid across different diseases and implementation settings, including transcultural implementation .Taking into consideration the diverse measurements to be undertaken to arrive at a truly future-orientated sustainable SME concept, it appears reasonable to not develop such a program for each integrated care concept separately, but jointly in a collaborative effort. Not only will such an approach be more economic, but several reasons regarding both content and delivery concept speak in favor for a collaborative effort: a person-centered self-management program should profit from a broad spectrum of expert experiences and knowledge, which in turn represents the basis for reaching a sustainable professional consensus and acceptance on content and structure of a future program; both an agile person-centered iterative design process and the development of supporting innovative digital components for such a future-orientated program require significant resources that can better be assured in a joint effort than in several smaller initiatives; ongoing formative and summative evaluation, especially for general program effectiveness, will be facilitated by a mutually agreed evaluation concept and set of measurement instruments.Last but not least, such a collaborative effort will be the best argument to convince statutory health insurers that PwPDs not only have the same rights as persons with other chronic diseases to benefit from the offer of a structured SME program, but that there also is a high-quality concept available worth being funded, supported both by a strong professional commitment and by a substantial body of evidence for program effectiveness.The outlined steps to achieve this goal can only be addressed with sufficient resources. For this, public funding needs to be assured through a grant proposal, currently under preparation. Professionals or institutions interested in contributing to this effort, e.g., as a clinical partner, as an expert in person-centered co-design processes, in the evaluation of complex healthcare interventions, or in the design of digitally supported cognitive behavioral therapy and/or SME programs are invited to contact the authors.