Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03851107
Other study ID # 151613
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date May 7, 2018

Study information

Verified date December 2021
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Youth with physical disabilities experience restrictions to participation in community-based activities, which can lead to poor health outcomes. Currently, activity-based treatment approaches that are client-centered and implemented in the youth's natural environment are considered recommended practice. It is unclear, however, whether targeting intervention at the activity and participation level (e.g. playing boccia) can result in improvement of body functions (e.g., joint mobility, balance) as well as in participation - two key outcomes of pediatric rehabilitation programs. Research suggests that the opportunity to practice therapist-prescribed exercise programs is positively associated with physical gains. However, the impact of participation in a chosen real-life activity that is meaningful to the youth on a range of body functions has not yet been established and effective methods for testing complex individual-based interventions and outcomes are lacking. With funding received from the Canadian Institutes of Health Research, the investigators have proven the effectiveness of the PREP intervention, i.e., Pathways and Resources for Engagement and Participation, in promoting youth participation in meaningful activities across two provinces. Using the PREP approach, the purpose of this pilot study is to 1) employ an interrupted time series (ITS) design in order to generate preliminary evidence on the effectiveness of participants engagement in a 6-week community-based activity program (e.g., team sledge hockey) on 3 body functions (i.e., motor, cognitive and affective) as well as on the performance of the selected activity. An 18-week interrupted time series design with multiple baselines across 8 participants with physical disabilities (e.g., cerebral palsy, spina bifida) will be employed. Each activity, individually selected by the participants, will be analyzed using the task analysis approach in order to identify the underlying body functions necessary for the chosen activity. These functions, i.e., motor (measured using the Spinal Alignment and Range of Motion Measure, the Functional Reach Test, the Trunk Impairment Scale and the Jamar dynamometer), cognitive and affective (using the Behavior Assessment System for Children), will then be measured multiple times throughout the entire study, resulting in overall 32 trajectories of change in body functions (8 participants X 3 body functions) and additional 8 trajectories representing change in activity performance (using the Canadian Occupational Performance Measure). Two experts will independently analyze each trajectory using visual inspection and an innovative analytical solution, i.e., a combination of segmented regression and mixed-effect modelling, will be performed to estimate the overall effectiveness of the intervention across participants. This interdisciplinary research team, including three researchers in the field of childhood disability (occupational therapy, physical therapy and pediatric medicine), has partnered with seven key stakeholders and will work collaboratively throughout the research process. This early study in the area will build knowledge about alternative clinical trials that can generate evidence applicable to practice. Findings can eventually inform decision-making by guiding clinicians, families and policy-makers in appraising the benefits of participation-based therapies on improving functional capacities and actual performance of meaningful life activities. Describing the multiple benefits potentially generated by one single intervention can facilitate the development of efficient youth-engaging therapies, and thereby contributing to the improvement of the provision of pediatric rehabilitation services.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date May 7, 2018
Est. primary completion date May 7, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada MAB-MACKAY Rehabilitation Center Montreal Quebec

Sponsors (4)

Lead Sponsor Collaborator
McGill University Canadian Institutes of Health Research (CIHR), McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 ?tted, 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; ).
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2