Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
BEYOND: Body-function Enhancement for YOuth Through participatioN in Real-worlD Contexts. The Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
October 16, 2023
October 1, 2023
2.9 years
March 13, 2023
October 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Behavioral Assessment System for Children
Evaluates the behavioral and emotional aspects of body functions using a 4-point scale. T-scores range from 0 to 120 in which lower scores indicate greater behavioral and emotional body functions.
22 weeks
Trunk Impairment Scale
Assesses trunk control and includes 3 sub-scales; static sitting balance, dynamic sitting balance and coordination. It contains 17 items rated on a 2-, 3- or 4- point scale. Total score measures motor body functions in terms of trunk control. Total score ranges from 0 (low performance) to 23 (high performance).
22 weeks
Functional Reach Test
Assesses motor body functions in terms of reaching. The maximum distance in inches the participant can reach forward while standing/sitting in a fixed position is measured; units: inches.
22 weeks
Jamar/Handheld micro Force Evaluation and Testing 2 (microFET2) Dynamometers
Measures motor body functions in terms of maximal grip, pinch strength and isometric muscle strength; units: pounds of force. Scores range from 0 to 200 pounds.
22 weeks
Goniometer
Measures active range of motion of specific joints relevant to the activity and based on the task analysis; units: degrees of range of motion.
22 weeks
Canadian Occupational Performance Measure
A gold-standard 10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well).
22 weeks
Other Outcomes (1)
Client Satisfaction Questionnaire
This outcome will be assessed once after the intervention (week 22).
Study Arms (1)
Community-based activity program
EXPERIMENTALEngagement in 8-week community-based activity program.
Interventions
Participants engage in a 8-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 8 weeks - the actual intervention phase.
Eligibility Criteria
You may qualify if:
- a physical disability (e.g., due to cerebral palsy, spina bifida, spinal cord injury, non progressive musculoskeletal disorders, juvenile arthritis);
- restricted mobility, such as an inability to navigate all surfaces and stairs independently and safely without the use of aids, physical assistance, or external support;
- youth with various diagnoses will be eligible;
- youth with cognitive and communication issues and/or intellectual delay will be included and a proxy version of self-reported assessments will be used.
- living in the province of Quebec or Ontario
You may not qualify if:
- youth who are recovering within the first year following a severe brain injury or an orthopedic surgery or botulinum toxin treatment 6 months prior or anticipated during the study period
- youth with degenerative disorders
- youth with a severe untreated mental health condition will also be excluded based on the Kessler Psychological Distress Scale (K6)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
- McMaster Universitycollaborator
- Drexel Universitycollaborator
Study Sites (1)
Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)
Montreal, Quebec, H4A 3J5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dana Anaby, PhD
McGill University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All assessors will be blinded to the time point in which the intervention begins and to the chosen activity.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
October 16, 2023
Record last verified: 2023-10