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N/A N=9 Treatment

The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities

Cerebral Palsy · Spina Bifida · Muscular Dystrophies · Musculoskeletal Disorder

Enrolled (actual)
9
Serious AEs
Results posted
Dec 2021
Primary outcome: Primary: Change in Behavioral Assessment System for Children — 54.73; -3.35; -0.05; 64.38 fixed effects estimate

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Engagement in 6-week community-based activity program (Behavioral)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
McGill University
Primary completion
May 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Behavioral Assessment System for Children
54.73; -3.35; -0.05; 64.38; 0.69; -0.01
PRIMARY
Change in Range of Motion Measure
NA
PRIMARY
Change in Trunk Impairment Scale
NA
PRIMARY
Change in Functional Reach Test
NA
PRIMARY
Change in Jamar Dynamometer Strength Test
NA
PRIMARY
Change in Canadian Occupational Performance Measure
2.59; 2.73; -0.49
PRIMARY
Change in Motor Outcomes
3.71; 1.57; 0.26

Summary

Youth with physical disabilities face greater restrictions to participation in community-based activities than their typically developing peers, which can lead to poor health outcomes. Emerging treatment approaches aimed at improving activity and participation have shifted from focusing only on impaired body functions towards the performance of functionally meaningful activities within the youth's natural environment. It is unclear, however, whether targeting intervention at the activity/participation level can, at the same time, result in improvement of personal functional skills (e.g., reaching) and body functions (e.g., range of motion) -components also important to address and maintain within the rehabilitation process. Together with key community-based stakeholders including youth/parents, clinicians, and policy-makers, the investigators plan, therefore, to examine whether engaging in a 6-week community based activity (e.g., joining a sledge hockey team, boccia) can lead to a significant improvement in three key body functions: motor, cognitive and affective functions. Eight participants with physical disabilities will take part in the study and engage in an activity program of their own choice. Changes in their body functions (e.g., movement-related functions, attention, behavior, mood) will be measured multiple times before, during and after the engagement in an individualized activity/program. Findings of this pilot study analyzed with input from key stakeholders can advance the investigators understanding about methods for testing complex and unique individual-based interventions. This can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but can also facilitate additional (motor and mental) benefits from one single intervention. Such findings may also reduce the burdens on the healthcare system as well as on the youth and families.

Eligibility Criteria

Inclusion Criteria

  • have a physical disability (e.g., cerebral palsy, spina bifida, musculoskeletal disorders, muscular dystrophy)
  • 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

Exclusion Criteria

  • Youth who are recovering within the first year following a severe brain injury or an orthopedic surgery will be excluded, as their functional capacities are less likely to be stable.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03851107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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