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

NCT03851107 | Completed Results

• 1 other identifier: 151613
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Spina Bifida; Muscular Dystrophies; Musculoskeletal Disorder

Keywords

participation; environmental barriers; youth; disabilities; body functions

Outcome Measures

Primary Outcomes (7)

• Change in Behavioral Assessment System for Children

  The Behavioral Assessment System for Children, Third Edition is a valid and reliable 2-point and 4-point scale for evaluating 18 subscales of global mental and emotional functions. Subscales (e.g. anxiety, attention) include 7 to 13 items. T scores calculated using Pearson's Q-global testing system ranged from 0 to 120, with lower scores indicating higher cognitive and affective functions. Six subscales measuring attention problems, hyperactivity, anxiety, sense of inadequacy, self-esteem, somatization were measured. For each subscale, we plotted the repeated T scores and fitted it into a regression line to represent the average change across the 7 participants. We report the results of the two-level hierarchical models estimating the overall intervention effect size for each of the 6 cognitive and affective outcomes.

  This outcome will be assessed repeatedly throughout the phases of the study of a period of 22 weeks: baseline (up to 11time-points; up to 11wks) intervention (8 time-points; 8wks) and follow-up (2-points, 4wks). A regression line fitted 22 observations.

• Change in Range of Motion Measure

  Measures motor body functions in terms of active/passive range of motion of lower and upper extremities. A score between 0 and 4 is calculated, with 4 being the most severe limitation in range of motion. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

  This outcome will be assessed biweekly during the study (22 weeks): baseline (up to 6 time-points; up to 11wks) intervention (4 time-points; 8wks) and follow-up (1-point, 4wks). A regression line fitted all motor-related trajectories outcomes.

• Change in 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 Measure motor body functions in terms of trunk control. Total score ranges from 0 (low performance) to 23 (high performance). The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

  This outcome will be assessed biweekly during the study (22 weeks): baseline (up to 6 time-points; up to 11wks) intervention (4 time-points; 8wks) and follow-up (1-point, 4wks). A regression line fitted all motor-related trajectories outcomes.

• Change in 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. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

  This outcome will be assessed biweekly during the study (22 weeks): baseline (up to 6 time-points; up to 11wks) intervention (4 time-points; 8wks) and follow-up (1-point, 4wks). A regression line fitted all motor-related trajectories outcomes.

• Change in Jamar Dynamometer Strength Test

  Measures motor body functions in terns of maximal grip strength; units: pounds of force. Scores range from 0 to 200 pounds. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

  This outcome will be assessed biweekly during the study (22 weeks): baseline (up to 6 time-points; up to 11wks) intervention (4 time-points; 8wks) and follow-up (1-point, 4wks). A regression line fitted all motor-related trajectories outcomes.

• Change in Canadian Occupational Performance Measure

  Canadian Occupational Performance Measure is a 10-point scale that measures activity performance. Score ranges from 1(unable to perform) to 10 (perform extremely well). A higher score represents higher perceived activity performance levels. A regression line was fitted to represent the average change for the 7 participants for performance (up to 22 observations).

  This outcome will be assessed repeatedly throughout the phases of the study over a period of 18-weeks: baseline (8 time-points; 8 wks) intervention (6 time-points; 6 wks) and follow-up (2-points, 4 wks) resulting in a total of 16 data-points.

• Change in Motor Outcomes

  Change in motor outcomes was determined by changes in scores (converted to standardized scores according to participant's baseline values) of range of motion (ROM), trunk impairment scale (TIS), functional reach test and Jamar dynamometer strength test (description of each outcome and its scores are presented in outcomes 2-5). We combined all motor-related trajectories outcomes into a regression line to represent the average change for all motor measures. A three-level hierarchical model was fitted, with observations nested within outcomes nested within participants. The results of the combined trajectories are presented (rather than the raw motor scores) as they are more suited to describe the change observed.

  This outcome will be assessed repeatedly throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-points, 4 wks; ).

Study Arms (1)

Community-based activity program

EXPERIMENTAL

Engagement in 6-week community-based activity program

Behavioral: Engagement in 6-week community-based activity program

Interventions

Engagement in 6-week community-based activity program BEHAVIORAL

Participants engage in a 6-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 6 weeks - the actual intervention phase.

Also known as: 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, 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• McMaster University: collaborator

Study Sites (1)

MAB-MACKAY Rehabilitation Center

Montreal, Quebec, H4A 3J5, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Spinal Dysraphism; Muscular Dystrophies; Musculoskeletal Diseases

Interventions

Health Resources

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; Muscular Disorders, Atrophic; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Dana Anaby
• Organization: McGill University

dana.anaby@mcgill.ca

15143984400

Study Officials

• Dana Anaby, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: An 18-week individual-based interrupted time series design with multiple baselines across 8 participants will be employed.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 22, 2019
• Study Start: September 1, 2017
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-12

Locations

CA (1)