Dataset Information

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial.

ABSTRACT:

Introduction

Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT.

Methods and analysis

One hundred children with CP, aged 8-14 years, classified Gross Motor Function Classification System levels I-IV will be randomised to either (1) receive Participate CP once/week for 1 hour for 12 weeks, or (2) waitlist control, usual care group. The waitlist group will then receive Participate CP following the 26-week retention time point. Outcomes will be assessed at baseline, 12 weeks and then 26 weeks post baseline. The primary outcomes are (1) self-reported participation goal performance on the Canadian Occupational Performance Measure at 12 weeks and (2) daily time in moderate-to-vigorous physical activity. Secondary outcomes include home and community participation frequency, involvement and environmental supportiveness, contextual barriers to participation, quality of life, intrinsic motivation for physical activities, child perception of an autonomy-supportive climate for physical activities and physical literacy at 12 and 26 weeks post study entry.

Ethics and dissemination

The Children's Health Queensland Hospital and Health Service, The University of Queensland and the New Zealand Health and Disability Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

ACTRN12618000206224.

SUBMITTER: Sakzewski L

PROVIDER: S-EPMC10551958 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial.

Sakzewski Leanne L Reedman Sarah Elizabeth SE Elliott Catherine C Ziviani Jenny J Novak Iona I Trost Stewart S Majnemer Annette A Comans Tracy T Shikako Keiko K Ware Robert S RS McNamara Lynda L Williams Sian S Keramat Syed Afroz SA Brookes Denise D Boyd Roslyn N RN

BMJ open 20231003 10

<h4>Introduction</h4>Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT.<h4 ...[more]

PMID: 37788925

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Project description:The participation of adolescents with cerebral palsy (CP) within the community is reduced compared to their peers and is a barrier to their socialization, self-determination and quality of life. Patient and Public Involvement (PPI) is a key strategy for successful interventions, especially when involvement of the stakeholders takes place at all stages of the research. Co-design can be crucial for success as researchers, patients with CP and their families work together to bring the necessary elements to the interventions to be designed. The objectives will be: (1) To co-design an intervention aimed at improving the participation of adolescents with significant motor disabilities within the community in partnership with adolescents with CP, families and rehabilitation professionals. (2) To assess the feasibility of the co-design process in partnership with interested parties. The study will be based on Participatory Action Research (PAR) and will be held in Spain and Brazil. In both countries, the study will be carried out remotely with nine adolescents aged 12 to 17 years with CP, Gross Motor Function Classification System (GMFCS) levels IV-V, their families and six health professionals (physiotherapists and occupational therapists). Different dialogue groups will be created to involve adolescents, families and health professionals to the research's project. To manage their involvement in the co-design process, the Involvement Matrix (IM) will be used, and according to the IM phases, four steps will be included in the research: (1) Preparation; (2) Co-design; (3) Analysis: results of the intervention protocol and the study's feasibility and (4) Dissemination of results. Partnering with the public to design an intervention to improve participation can bring better results compared to protocols designed only by health professionals. In addition, it will allow for knowing the needs of adolescents with CP in terms of participation within the community. The study will also explore which roles were chosen by all participants and how they felt while actively participating in the process of co-designing an intervention protocol and their own perspectives on the use of the involvement matrix.

Project description:BackgroundFolate prevents neural tube defects and may play a role in some neurodevelopmental disorders.ObjectivesWe investigated whether higher intakes of periconceptional or midpregnancy folate, as recommended, were associated with a reduced risk of offspring cerebral palsy (CP).MethodsWe included participants from the Nordic collaboration cohort consisting of mother-child dyads in the Danish National Birth Cohort and the Norwegian Mother, Father, and Child Cohort Study [combined as MOthers and BAbies in Norway and Denmark (MOBAND-CP)]. A total of 190,989 live-born children surviving the first year of life were included. Missing covariate data were multiply imputed. Our exposures were defined as any or no folic acid supplementation in gestational weeks (GWs) -4 to 8 (periconceptional), 9 to 12, and -4 to 12, and supplemental, dietary, and total folate during midpregnancy (GWs 22-25). CP overall and the unilateral and bilateral spastic subtypes, as well as CP with low or moderate/high gross motor function impairments, were our outcomes of interest.ResultsPericonceptional folic acid supplementation was not associated with CP [adjusted odds ratio (aOR), 1.02; 95% CI: 0.82-1.28]. However, supplementation in GWs 9 to 12 was associated with a reduced risk of CP (aOR, 0.74; 95% CI: 0.57-0.96), and inverse associations were indicated for both the unilateral (aOR, 0.68; 95% CI: 0.46-1.02) and bilateral (aOR, 0.70; 95% CI: 0.49-1.02) spastic subtypes, although the associations were not statistically significant. Supplemental or dietary folate in midpregnancy alone were not associated with CP. Strong inverse associations were observed with low gross motor function impairment (aOR, 0.49; 95% CI: 0.29-0.83), while for unilateral CP the aOR was 0.63 (95% CI: 0.34-1.22) for intakes of ≥500 compared to ≤199 dietary folate equivalents/day during midpregnancy.ConclusionsOur findings suggest that folate intakes in GWs 9 to 12 and midpregnancy were associated with lower risks of CP, while no association was observed for periconceptional supplementation.

Project description:IntroductionFor children with cerebral palsy (CP), who are marginally ambulant, gross motor capacity peaks between 6 and 7 years of age with a subsequent clinical decline, impacting their ability to engage in physical activity. Active Strides-CP is a novel package of physiotherapy targeting body functions, activity and participation outcomes for children with bilateral CP. This study will compare Active Strides-CP to usual care in a multisite randomised waitlist-controlled trial.Methods and analysis150 children with bilateral CP (5-15 years), classified in Gross Motor Function Classification System (GMFCS) levels III and IV will be stratified (GMFCS III vs IV, age 5-10 years; 11-15 years and trial site) and randomised to receive either (1) 8 weeks of Active Strides-CP two times/week for 1.5 hours in clinic and one time/week for 1 hour alternating home visits and telehealth (total dose=32 hours) or (2) usual care. Active Strides-CP comprises functional electrical stimulation cycling, partial body weight support treadmill training, overground walking, adapted community cycling and goal-directed training. Outcomes will be measured at baseline, immediately post-intervention at 9 weeks primary endpoint and at 26 weeks post-baseline for retention. The primary outcome is the Gross Motor Function Measure-66. Secondary outcomes include habitual physical activity, cardiorespiratory fitness, walking speed and distance, frequency/involvement of community participation, mobility, goal attainment and quality of life. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. A within-trial cost utility analysis will be performed.Ethics and disseminationThe Children's Health Queensland Hospital and Health Service, The University of Queensland, The University of Melbourne and Curtin University Human Research Ethics Committees have approved this study. Results will be disseminated as conference abstracts and presentations, peer-reviewed articles in scientific journals, and institution newsletters and media releases.Trial registration numberACTRN12621001133820.

Project description:IntroductionPoverty is a key contributor to delayed diagnosis and limited access to early intervention and rehabilitation for children with cerebral palsy (CP) in rural Bangladesh. 97% of families of children with CP live below the poverty line in Bangladesh. Therefore, in low-and middle-income countries (LMICs), efforts to improve outcomes for children with CP (including health-related quality of life, motor function, communication, and nutritional attainments) should also include measures to improve family economic and social capital. We propose a randomised controlled trial (RCT) to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh.Material and methodsThis will be a cluster RCT comparing three arms: (a) integrated microfinance/livelihood and community-based rehabilitation (IMCBR); (b) community-based rehabilitation (CBR) alone; and (c) care-as-usual (i.e. no intervention). Seven clusters will be recruited within each arm. Each cluster will consist of 10 child-caregiver dyads totalling 21 clusters with 210 dyads. Parents recruited in the IMCBR arm will take part in a microfinance/livelihood program and Parent Training Module (PTM), their children with CP will take part in a Goal Directed Training (GDT) program. The programs will be facilitated by specially trained Community Rehabilitation Officers. The CBR arm includes the same PTM and GDT interventions excluding the microfinance/livelihood program. The care-as-usual arm will be provided with information about early intervention and rehabilitation. The assessors will be blinded to group allocation. The duration of the intervention will be 12 months; outcomes will be measured at baseline, 6 months, 12 months, and 18 months.ConclusionThis will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving wellbeing of children with CP and their ultra-poor families.

Project description:Background/Objectives: Children with cerebral palsy (CP) are reported to have lower rates of participation in community and home tasks than typically developing children. Little is known about the participation levels of children with CP and the environmental factors influencing their participation in the community within the Saudi context. This study aimed to determine the degree of participation in community and home tasks in children with CP in Saudi Arabia, as well as the level of support received, and the obstacles faced by children in this context. Methods: Parents of 5-16-year-old children with CP (n = 50) completed the Participation and Environment Measure for Children and Youth (PEM-CY), and their scores were compared with those of typically developing children of the same ages (n = 50). This study was conducted in a hospital setting. Analyses were performed using multivariate logistic regression analyses, controlling for potential confounders. Results: Participation in community activities as well as home activities was reported to be significantly lower in children with CP compared to their typically developing peers in multiple domains (p < 0.05). Additionally, physical, cognitive, and social demands were identified as factors that made community participation more difficult for children with CP (p = 0.002, p = 0.017, and p = 0.029 for physical, cognitive, and social demands, respectively). The availability of personal transportation, programs, services, and financial support were identified by parents as the factors that lowered community participation levels in children with CP (p > 0.005). Conclusions: Physical, cognitive, and social demands are the main obstacles to participation for children with CP. A lack of home supplies and financial support lowered the participation of children with CP. Recognizing environmental barriers as well as providing individualized practical solutions in collaboration with the families of children with CP can assist in developing meaningful participation in community and home activities for children with CP.

Project description:IntroductionCerebral palsy (CP) is a childhood onset, lifelong, condition. Early detection and timely treatment of potential problems during the child's development are important to prevent secondary impairments and improve function. Clinical management of children with CP requires a spectrum of multidisciplinary interventions, which have an impact on short-term and long-term outcomes. However, there is a lack of knowledge about a personalised approach in this heterogeneous population. Various CP registers with different aims have been developed worldwide, which has made an important contribution to our understanding of CP. The purpose of this protocol is to describe the unique design of a combined multidisciplinary surveillance and treatment register for children with CP in the Netherlands, which aims to improve quality of care and to enhance an individual treatment approach.Methods and analysisThe Netherlands CP Register combines a multidisciplinary surveillance programme with a standardised protocol for treatment registry. The register systematically collects real-life surveillance and treatment data of children with CP. The register contributes to daily care at the individual level by screening for potential secondary impairments using a decision-support tool, by visualising individual development using a dashboard, and by supporting goal setting and shared decision-making for interventions. The register provides a platform at the national level for quality of care improvement and a comprehensive database of real-life data allowing multicentre studies with a long-term follow-up. People with lived experience of CP, healthcare professionals from different disciplines and researchers collaborated in the development of the register.Ethics and disseminationThe Netherlands CP register was submitted to the Medical Ethics Review Committee of VU University Medical Center (Amsterdam, the Netherlands), who judged the register not to be subject to the Medical Research Involving Human Subjects Act. A scientific board reviews requests for dissemination of data from the register for specific research questions.

Dataset Information

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial.

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