The Impact of Participation on Body Functions Among Youth With Physical Disabilities

NCT04288453 | Unknown

• 1 other identifier: 419713
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Youth with physical disabilities experience greater limitations to participation in community- based activities than do their average-developing peers, which can result in 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 simultaneously result in improvement of personal functional skills (e.g., reaching) and body functions (e.g., range of motion, balance) - components known to worsen with age and, thus, important to address and maintain within the rehabilitation process. Our team has partnered with key community-based stakeholders including youth, clinicians and policy-makers, and together we plan to examine whether engaging in an 8-week self-chosen community-based activity (e.g., sledge hockey, boccia) can lead to a significant improvement in three key body functions: motor, cognitive and affective. Thirty youth with physical disabilities will take part in the study and engage in an activity program of their 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/program. 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 one single intervention. Such treatment approaches may also reduce the burden on the healthcare system as well as on the youth and families. Moreover, findings can advance our understanding of methods for testing complex and unique 'real-life' individual-based interventions that are highly relevant to practice.

Conditions

Cerebral Palsy; Spina Bifida; Musculoskeletal Disorders

Keywords

participation; environmental barriers; youth; disabilities; body functions

Outcome Measures

Primary Outcomes (6)

• Behavioral Assessment System for Children

  Evaluates cognitive and affective body functions using a 4-point scale. T-scores range from 0 to 120 in which lower scores indicate greater cognitive and affective 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

  10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well).

  22 weeks

Other Outcomes (1)

• Life-Habits (LIFE-H)

  This outcome will be assessed once at baseline only (week 1).

Study Arms (1)

Community-based activity program

EXPERIMENTAL

Engagement in 8-week community-based activity program

Behavioral: Engagement in a 8-week community-based activity program

Interventions

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

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. Other Names: • Pathways and Resources for Engagement and Participation

Community-based activity program

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

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 or those with degenerative disorders will be excluded.
• Youth with significant intellectual delay will be excluded due to the demands required for completing self-reported assessments.
• Youth with co-occurrence of an untreated mental health condition will also be excluded.

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster University: collaborator
• Drexel University: collaborator

Study Sites (1)

Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)

Montreal, Quebec, H4A 3J5, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Spinal Dysraphism; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dana Anaby, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 22-week interrupted time series design with multiple baselines systematically replicated across 30 youth with physical disabilities will be employed.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: August 24, 2020
• Primary Completion: May 24, 2022
• Study Completion: October 1, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

CA (1)