Spinal Cord InjuriesNCT05784285
Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
A study testing Engagement in a 8-week community-based activity program in people with Spinal Cord Injuries and Spina Bifida, run by McGill University at 1 site in Canada.
Trial summary
Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Spinal Cord Injuries, Spina Bifida, Musculoskeletal Disorder
- 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
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- a physical disability (e.g., due to cerebral palsy, spina bifida, spinal cord injury, non progressive musculoskeletal disorders, juvenile arthritis);
- 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;
- youth with various diagnoses will be eligible;
- youth with cognitive and communication issues and/or intellectual delay will be included and a proxy version of self-reported assessments will be used.
- living in the province of Quebec or Ontario
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
- youth with degenerative disorders
- youth with a severe untreated mental health condition will also be excluded based on the Kessler Psychological Distress Scale (K6)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)
Montreal, Quebec, H4A 3J5
About this study
Official title: BEYOND: Body-function Enhancement for YOuth Through participatioN in Real-worlD Contexts. The Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity/participation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of 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. 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 a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.
Read the detailed description
Youth with physical disabilities experience restrictions to participation in community-based activities, leading to poor health outcomes. Typical treatment approaches focusing on remediation of impaired body functions ('bottom-up' or upstream approach) have failed to translate into improved participation. As such, reverse 'top-down' participation-based approaches, implemented in one's natural environment, are emerging; yet, their downstream effects have not been established. Specifically, it is unclear whether enhancing participation in self-chosen real-life activity that is meaningful to the youth (e.g., sledge hockey) can simultaneously improve both body functions (e.g., grip strength, attention, anxiety) and activity performance - two key outcomes in pediatric rehabilitation.
Supported by CIHR (2013-17), investigators first proved the effectiveness of PREP intervention (Pathways and Resources for Engagement and Participation) in promoting youth's community participation; then, through SPOR (2017-18) and CIHR Project Grant (2020-23), investigators successfully tested an innovative pragmatic clinical trial to improve body functions through participation. Investigators' promising findings inform the design of this proposed larger more rigorous cross-provincial study called BEYOND, generating sound evidence with widening impact which will serve to support a paradigm shift in clinical practice.
Using PREP, investigators aim to determine the effectiveness of youth engagement in self-chosen 8-week community- based activity program (e.g., drawing, swimming) on change in 3 underlying body functions: motor (using the Functional Reach Test, Trunk Impairment Scale, and dynamometers), behavioral and emotional (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 across 150 youth with physical disabilities (e.g., cerebral palsy, spina bifida) stratified by sex and severity, aged 12 to 18 living in Quebec and Ontario will be employed. Body functions relevant to each activity will be measured multiple times throughout the entire study and during follow-up, resulting in 450 trajectories of change in body functions (150 youth X 3 functions) and 150 trajectories representing change in activity performance. Mixed-effects models will be used to estimate an intervention effect across youth. Investigators' interdisciplinary team, comprised of researchers in the field of childhood disability and transition-aged youth (occupational therapy, physical therapy, psychology, biostatistics), has partnered with CIUSSS West- Central Montreal and Empowered Kids Ontario, and is well-positioned to accomplish the study objectives.
This novel patient-oriented study will permit drawing firm conclusions to support a shift towards personalized 'top-down' approaches in clinical practice. It will 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. Demonstrating 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 that are most appropriate and beneficial for rehabilitation research and practice.
- Conditions
- Spinal Cord Injuries, Spina Bifida, Musculoskeletal Disorder, Juvenile Arthritis, Amputation, Cerebral Palsy
- Being tested
- Engagement in a 8-week community-based activity program
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Medical subject headings
- Spinal Cord Injuries, Spinal Dysraphism, Musculoskeletal Diseases, Arthritis, Juvenile, Cerebral Palsy
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
Also called Pathways and Resources for Engagement and Participation (PREP)
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.
| 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 the behavioral and emotional aspects of body functions using a 4-point scale. T-scores range from 0 to 120 in which lower scores indicate greater behavioral and emotional 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
A gold-standard 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 posted24 Mar 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 across 150 youth with physical disabilities stratified by sex and severity will be employed.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- Sponsor
- Investigators
- Dana Anaby, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784285
- Sponsor's protocol ID
- 480889
- Status last verified
- Oct 2023
- First submitted
- 13 Mar 2023
- Last updated
- 16 Oct 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEYOND: Body-function Enhancement for YOuth Through participatioN in Real-worlD Contexts. The Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
- ClinicalTrials.gov ID
- NCT05784285
- Acronym / sponsor ID
- 480889
- Conditions
- Spinal Cord Injuries, Spina Bifida, Musculoskeletal Disorder, Juvenile Arthritis, Amputation, Cerebral Palsy
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster University, Drexel University
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Mar 2023 (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.
Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity/participation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of 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. 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 a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.
Detailed description
Youth with physical disabilities experience restrictions to participation in community-based activities, leading to poor health outcomes. Typical treatment approaches focusing on remediation of impaired body functions ('bottom-up' or upstream approach) have failed to translate into improved participation. As such, reverse 'top-down' participation-based approaches, implemented in one's natural environment, are emerging; yet, their downstream effects have not been established. Specifically, it is unclear whether enhancing participation in self-chosen real-life activity that is meaningful to the youth (e.g., sledge hockey) can simultaneously improve both body functions (e.g., grip strength, attention, anxiety) and activity performance - two key outcomes in pediatric rehabilitation.
Supported by CIHR (2013-17), investigators first proved the effectiveness of PREP intervention (Pathways and Resources for Engagement and Participation) in promoting youth's community participation; then, through SPOR (2017-18) and CIHR Project Grant (2020-23), investigators successfully tested an innovative pragmatic clinical trial to improve body functions through participation. Investigators' promising findings inform the design of this proposed larger more rigorous cross-provincial study called BEYOND, generating sound evidence with widening impact which will serve to support a paradigm shift in clinical practice.
Using PREP, investigators aim to determine the effectiveness of youth engagement in self-chosen 8-week community- based activity program (e.g., drawing, swimming) on change in 3 underlying body functions: motor (using the Functional Reach Test, Trunk Impairment Scale, and dynamometers), behavioral and emotional (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 across 150 youth with physical disabilities (e.g., cerebral palsy, spina bifida) stratified by sex and severity, aged 12 to 18 living in Quebec and Ontario will be employed. Body functions relevant to each activity will be measured multiple times throughout the entire study and during follow-up, resulting in 450 trajectories of change in body functions (150 youth X 3 functions) and 150 trajectories representing change in activity performance. Mixed-effects models will be used to estimate an intervention effect across youth. Investigators' interdisciplinary team, comprised of researchers in the field of childhood disability and transition-aged youth (occupational therapy, physical therapy, psychology, biostatistics), has partnered with CIUSSS West- Central Montreal and Empowered Kids Ontario, and is well-positioned to accomplish the study objectives.
This novel patient-oriented study will permit drawing firm conclusions to support a shift towards personalized 'top-down' approaches in clinical practice. It will 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. Demonstrating 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 that are most appropriate and beneficial for rehabilitation research and 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 across 150 youth with physical disabilities stratified by sex and severity 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
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- a physical disability (e.g., due to cerebral palsy, spina bifida, spinal cord injury, non progressive musculoskeletal disorders, juvenile arthritis);
- 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;
- youth with various diagnoses will be eligible;
- youth with cognitive and communication issues and/or intellectual delay will be included and a proxy version of self-reported assessments will be used.
- living in the province of Quebec or Ontario
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
- youth with degenerative disorders
- youth with a severe untreated mental health condition will also be excluded based on the Kessler Psychological Distress Scale (K6)
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 programAlso: Pathways and Resources for Engagement and Participation (PREP)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. | Behavioural | Community-based activity program |
Primary outcome
Behavioral Assessment System for Children
Time frame: 22 weeks
Evaluates the behavioral and emotional aspects of body functions using a 4-point scale. T-scores range from 0 to 120 in which lower scores indicate greater behavioral and emotional 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
A gold-standard 10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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.
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 Spinal Cord Injuries 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 5 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: opening soon, as of the sponsor's last update on 16 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Anaby, PhD (15143984400, dana.anaby@mcgill.ca), or a site near the patient. 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 16 Oct 2023.