Cerebral PalsyNCT04288453
The Impact of Participation on Body Functions Among Youth With Physical Disabilities
A study testing Engagement in a 8-week community-based activity program in people with Cerebral Palsy and Spina Bifida, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Cerebral Palsy, Spina Bifida, Musculoskeletal Disorders
- What is being tested?
- Engagement in a 8-week community-based activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2020to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)
Montreal, Quebec, H4A 3J5
About this study
Official title: The Impact of Participation on Body Functions Among Youth With Physical Disabilities: A Pragmatic Individual-based Study
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.
Read the detailed 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.
- Conditions
- Cerebral Palsy, Spina Bifida, Musculoskeletal Disorders
- Being tested
- Engagement in a 8-week community-based activity program
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Medical subject headings
- Cerebral Palsy, Spinal Dysraphism, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement in a 8-week community-based activity programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Community-based activity program | Experimental | Engagement in 8-week community-based activity program Receives: Behavioral: Engagement in a 8-week community-based activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start24 Aug 2020
- Primary completion24 May 2022
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A 22-week interrupted time series design with multiple baselines systematically replicated across 30 youth with physical disabilities will be employed.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster University, Drexel University
- Responsible party
- Principal investigator, Dana Anaby, McGill University
- Investigators
- Dana Anaby, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288453
- Sponsor's protocol ID
- 419713
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Participation on Body Functions Among Youth With Physical Disabilities: A Pragmatic Individual-based Study
- ClinicalTrials.gov ID
- NCT04288453
- Acronym / sponsor ID
- 419713
- Conditions
- Cerebral Palsy, Spina Bifida, Musculoskeletal Disorders
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster University, Drexel University
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 22-week interrupted time series design with multiple baselines systematically replicated across 30 youth with physical disabilities will be employed.
| Arm | Type | Receives |
|---|---|---|
| Community-based activity program | Experimental | Behavioral: Engagement in a 8-week community-based activity programEngagement in 8-week community-based activity program |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engagement in a 8-week community-based activity programParticipants 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 | Behavioural | Community-based activity program |
Primary outcome
Behavioral Assessment System for Children
Time frame: 22 weeks
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.
Trunk Impairment Scale
Time frame: 22 weeks
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).
Functional Reach Test
Time frame: 22 weeks
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.
Jamar/Handheld micro Force Evaluation and Testing 2 (microFET2) Dynamometers
Time frame: 22 weeks
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.
Goniometer
Time frame: 22 weeks
Measures active range of motion of specific joints relevant to the activity and based on the task analysis; units: degrees of range of motion.
Canadian Occupational Performance Measure
Time frame: 22 weeks
10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Anaby, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engagement in a 8-week community-based activity program in people with Cerebral Palsy and Spina Bifida, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Assessment System for Children (time frame: 22 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.