Cerebral PalsyNCT03851107
The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities
A study testing Engagement in 6-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 face greater restrictions to participation in community-based activities than their typically developing peers, which can lead to 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, Muscular Dystrophies
- What is being tested?
- Engagement in 6-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
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 7 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities: An Interrupted Time Series Design
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.
Read the detailed 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.
- Being tested
- Engagement in 6-week community-based activity program
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Medical subject headings
- Cerebral Palsy, Spinal Dysraphism, Muscular Dystrophies, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement in 6-week community-based activity programBehavioural
Also called Pathways and Resources for Engagement and Participation
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-based activity program | Experimental | Engagement in 6-week community-based activity program Receives: Behavioral: Engagement in 6-week community-based activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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.
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 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.
Measured: 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; ).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Sep 2017
- Primary completion7 May 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- An 18-week individual-based interrupted time series design with multiple baselines across 8 participants will be employed.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University
- Responsible party
- Principal investigator, Dana Anaby, McGill University
- Investigators
- Dana Anaby, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851107
- Sponsor's protocol ID
- 151613
- Status last verified
- Dec 2021
- First submitted
- 14 Feb 2019
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities: An Interrupted Time Series Design
- ClinicalTrials.gov ID
- NCT03851107
- Acronym / sponsor ID
- 151613
- Keywords
- participation, environmental barriers, youth, disabilities, body functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 14 Dec 2021
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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An 18-week individual-based interrupted time series design with multiple baselines across 8 participants will be employed.
| Arm | Type | Receives |
|---|---|---|
| Community-based activity program | Experimental | Behavioral: Engagement in 6-week community-based activity programEngagement in 6-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, 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
Key exclusion criteria (1 listed)
- 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.
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 6-week community-based activity programAlso: Pathways and Resources for Engagement and ParticipationParticipants 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. | Behavioural | Community-based activity program |
Primary outcome
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.
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.
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.
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.
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.
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 6-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 1 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: finished, as of the sponsor's last update on 14 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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 study lists 7 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 14 Dec 2021.