- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851107
The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities
The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities: An Interrupted Time Series Design
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H4A 3J5
- MAB-MACKAY Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Community-based activity program
Engagement in 6-week community-based activity program
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Assessment System for Children
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
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Change in Motor Outcomes
Time Frame: 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; ).
|
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; ).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- Nervous System Malformations
- Neural Tube Defects
- Cerebral Palsy
- Muscular Dystrophies
- Musculoskeletal Diseases
- Spinal Dysraphism
Other Study ID Numbers
- 151613
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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