Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04288453 |
| Other study ID # |
419713 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 24, 2020 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
February 2023 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Youth with physical disabilities experience restrictions to participation in community-based
activities, leading to poor health outcomes. Personalized participation-based treatment
approaches, implemented in the individual's natural environment, are considered recommended
practice. However, it is unclear whether enhancing participation (e.g., engaging in sledge
hockey) can simultaneously improve both body functions (e.g., grip, trunk control) and
activity performance - two key outcomes in pediatric rehabilitation. Specifically, the impact
of participation in a self-chosen real-life activity, that is meaningful to the youth, on a
range of functions (motor, cognitive and affective) has not been established. Supported by
Canadian Institutes of Health Research (CIHR), we first proved the effectiveness of the
Pathways and Resources for Engagement and Participation (PREP) intervention in promoting
youth's community participation; then, through Strategy for Patient-Oriented Research (SPOR),
we successfully pilot- tested an innovative pragmatic clinical trial to improve body
functions through participation, informing the design of this proposed larger study. Using
the PREP, we aim to examine the impact of youth engagement in an 8-week community-based
activity program (e.g., drawing, swimming) on underlying body functions or impairments (e.g.,
movement, attention, mood), as well as on performance of the selected activity. Specifically,
change in 3 relevant body functions will be examined: motor (using the Functional Reach Test,
Trunk Impairment Scale, and dynamometer), cognitive and affective (using the Behavior
Assessment System for Children), and activity performance (via the Canadian Occupational
Performance Measure). A 22-week interrupted time series design with multiple baselines
systematically replicated across 30 youth with physical disabilities (e.g., cerebral palsy,
spina bifida) aged 15 to 24 will be employed. Each activity, individually selected by the
youth, will be analyzed using the task analysis approach to identify underlying body
functions. These functions will be measured multiple times throughout the entire study,
resulting in 90 trajectories of change in body functions (30 youth X 3 functions) and 30
trajectories representing change in activity performance. A linear model will be fit for each
of the 120 trajectories. Motor-related scores will be standardized to allow comparison across
different outcomes and mixed-effects models will be used to estimate an intervention effect
across participants. Our interdisciplinary team includes researchers in the field of
childhood disability, including occupational therapy, physical therapy and pediatric
medicine. Partnered with the Centre of Integrated University Health and Social Services
(CIUSSS) West-Central Montreal and CanChild Centre for Childhood Disability, as well as key
local and national stakeholders, the team will collaborate throughout the research process.
This novel patient-oriented study will support a paradigm shift in clinical practice and
build knowledge that can guide clinicians, families and policy-makers in appraising the
benefits of participation- based therapies on improving both functional capacities and
performance in meaningful life activities. Describing the multiple benefits generated by one
single intervention can facilitate efficient youth-engaging therapies, contributing to the
provision of pediatric rehabilitation services. Findings can also enhance knowledge of
pragmatic clinical trials for testing complex individual-based interventions highly
applicable to practice.
