Community-Based Activity Program for Physical Disabilities

Overseen By Dana Anaby, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Severe brain injury, Orthopedic surgery, Botulinum toxin, Degenerative disorders, Severe untreated mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity/participation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of choice. Changes in their body functions (e.g., movement, attention, mood) will be measured multiple times before, during and after engagement in the chosen activity. Findings of this study can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but also facilitate additional motor and mental benefits from a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on participation in community activities rather than medication changes.

What data supports the effectiveness of the treatment Engagement in an 8-week community-based activity program for physical disabilities?

Research shows that community-based activity programs can improve social inclusion and well-being for adults with physical disabilities. Additionally, similar programs have been effective in promoting exercise and improving quality of life for people with disabilities, including those who use wheelchairs. ^{1 2 3 4 5}

Is the community-based activity program for physical disabilities safe for humans?

The research mentions safety outcomes (adverse events) for community-based physical activity interventions in people with complex cerebral palsy, suggesting that safety is considered in these programs. ^{4 6 7 8 9}

How is the community-based activity program treatment different from other treatments for physical disabilities?

This treatment is unique because it focuses on engaging people with physical disabilities in a community-based activity program, which is designed to be more accessible and inclusive compared to traditional rehabilitation or school-based programs. It aims to improve physical activity and social inclusion by providing opportunities for leisure-time physical activity in a supportive community setting. ^{1 3 4 7 10}

Research Team

Dana Anaby, PhD

Principal Investigator

McGill University

Eligibility Criteria

This trial is for youth with physical disabilities like cerebral palsy, spina bifida, or juvenile arthritis in Quebec or Ontario. Participants should have restricted mobility but can't join if they're recovering from severe brain injury, recent orthopedic surgery, botulinum toxin treatment within the last 6 months, have degenerative disorders or untreated severe mental health conditions.

Inclusion Criteria

I have a physical disability like cerebral palsy or spinal cord injury.

Patients living in the province of Quebec or Ontario

I have cognitive, communication issues, or intellectual delays and will use a proxy for assessments.

Exclusion Criteria

I am a young person with a degenerative disorder.

Youth with a severe untreated mental health condition will also be excluded based on the Kessler Psychological Distress Scale (K6)

I am a young person recovering from a severe brain injury or had orthopedic surgery or botulinum toxin treatment within the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of body functions and activity performance before intervention

1 week

1 visit (in-person)

Treatment

Participants engage in an 8-week community-based activity program individually chosen by the youth

8 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in body functions and activity performance after the intervention

14 weeks

Multiple assessments (in-person)

Treatment Details

Interventions

• Engagement in a 8-week community-based activity program

Trial Overview The study tests an 8-week personalized community-based activity program to see if it improves motor skills and emotional and behavioral functions among youths with physical disabilities. The activities are chosen by the participants themselves to gauge motivation and overall well-being improvement.

Participant Groups

Group I: Community-based activity program Experimental Treatment 1 Intervention

Engagement in 8-week community-based activity program.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Examination of Leisure-Time Physical Activity (LTPA), Participation, and Social Inclusion Upon Joining a Community-based LTPA Program for Adults With Physical Disabilities. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Do community-based rehabilitation programmes promote the participation of persons with disabilities? A case control study from Mandya District, in India. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

An exercise trial for wheelchair users: project workout on wheels. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Community Partners' Perspectives on Partnering With an Academic Research Team to Promote Disability-inclusive Fitness Programming. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Effects of Occupation-Based Community Rehabilitation for Improving Activities of Daily Living and Health-Related Quality of Life of People with Disabilities after Stroke Living at Home: A Single Subject Design. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Community-based physical activity interventions for adolescents and adults with complex cerebral palsy: A scoping review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Development of an intervention to stimulate physical activity in hard-to-reach physically disabled people and design of a pilot implementation: an intervention mapping approach. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Park-based physical activity interventions for persons with disabilities: A mixed-methods systematic review. [2019]

9. Sweden pubmed.ncbi.nlm.nih.gov

Perceived barriers to and facilitators of physical activity in young adults with childhood-onset physical disabilities. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Optimising leisure participation: a pilot intervention study for adolescents with physical impairments. [2017]