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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| University of Toronto | OTHER |
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The purpose of this study is to compare a motor learning (ML)-based gait-related training intervention to a functional lower limb strength training intervention, with a concurrent evaluation of functional, neural and participation outcomes for children and youth with Cerebral Palsy (CP).
This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BeFAST | Active Comparator | Motor learning-based program involving athletic lower extremity training of gait-related skills. |
|
| BeSTRONG | Active Comparator | Lower limb strength training program involving progressive muscle resistance exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BeFAST | Behavioral | The motor learning (ML)-based gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined training/home imagery) will be five per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in advanced motor skills on the Challenge Module | The Challenge Module is a new published measure of advanced motor skills. | 7 days pre/7 days post/4-months post training intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI) | 7 days pre/7 days post training intervention | |
| Change from baseline in resting state activity, assessed using resting state fMRI | 7 days pre/7 days post training intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Motor learning as evaluated using retention and transfer tests | Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning | Week 2, 4, 6 |
| Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Wright | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G 1R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36524254 | Derived | Hilderley AJ, Wright FV, Taylor MJ, Chen JL, Fehlings D. Functional Neuroplasticity and Motor Skill Change Following Gross Motor Interventions for Children With Diplegic Cerebral Palsy. Neurorehabil Neural Repair. 2023 Jan;37(1):16-26. doi: 10.1177/15459683221143503. Epub 2022 Dec 15. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| BeSTRONG | Behavioral | The functional strength training program is designed to improve gait-related skills. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down. Children will be given a 3- to 5-min home program of strength exercises to practice on days when they do not have active training sessions. The total number of sessions (combined training/home program) will be five per week. |
|
| Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI) | 7 days pre/7 days post training intervention |
| Change from baseline in Physical Activity self-efficacy | Participant-report measure of Task efficacy and Barrier efficacy for physical activity. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in walking activity, assessed using an Actigraph accelerometer | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in gait kinematics as measured using an electronic walkway | Time/distance parameters of footsteps via GAITRite system. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY) | Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in walk speed on the Six-minute walk test | Standardized 6 minute walk test (with shoes, orthoses as required) to determine distance covered (capability measure). Well-validated in pediatric CP. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure | Three to five individualized walking-based activity/participation set at baseline with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessments | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) | Three to five individualized walking-based activity/participation set at baseline with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessments | 7 days pre/7days post/4-months post training intervention |
The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session |
| Week 2, 4, 6 |
| Intervention program enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES) | Participants' enjoyment of the intervention program will be assessed following the intervention | 7 days post training intervention |
| Intervention session enjoyment | Participants' enjoyment of each session will be assessed using a study-specific questionnaire | 16 times over 6 weeks (following each intervention session) |
| Rating of exertion, assessed using Pictorial Children's Effort Rating Table (PCERT) | Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion | Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session |
| Heart rate (beats per minute) | Heart rate will be monitored by treating staff member via radial pulse. | Assessed at 4 time points per session: 1 min before start of session, at 22 minutes (mid-point), at 43-minutes (2-min before end), and at 45-minutes (end) of each session |
| Body pain | Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other) | Completed 2 minutes before and 2 minutes after each intervention session |
| Parent Satisfaction scale | Parent's satisfaction and perceived benefit of intervention will be assessed using a study-specific questionnaire | 7 days post training intervention |
| Staff Satisfaction scale | Staff satisfaction and perceived benefit of intervention for each child in the study will be assessed using a study-specific questionnaire | 7 days post training intervention |
| Lower limb strength | A 30 second lateral step-up test will be used bilaterally to assess functional lower limb strength | 7 days pre/7days post/4-months post intervention |
| Ankle range of motion and dorsiflexion force | Passive and active ROM will be assessed using a goniometer | 7 days pre/7days post/4-months post intervention |
| Dorsiflexion force | Dorsiflexion force will be assessed using surface electromyography (EMG) | 7 days pre/7days post/4-months post intervention |
| Change from baseline in lower-limb proprioception | Lower limb joint-sense position will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009) | 7 days pre/7days post/4-months post intervention |
| Mental chronometry | Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance. | 7 days pre/7days post/4-months post intervention |
| Motor Imagery Questionnaire for Children (MIQ-C) | Participant's motor imagery ability will be assessed using the 12-item MIQ-C | 7 days pre/7days post/4-months post intervention |
| Feasibility process indicators: recruitment rate | Recruitment rate: # eligible participants as compared to # screened and # enrolled | Through study completion, an average of 6-months |
| Feasibility process indicators: perceived intervention benefit | Perceived intervention benefit calculated as combined child/parent rating | Through study completion, an average of 6-months |
| Feasibility process indicators: retention rate | Number of children enrolled as compared to number of children who complete the study | Through study completion, an average of 6-months |
| Feasibility resource indicators: adherence rate | Number of sessions completed | Through study completion, an average of 6-months |
| Feasibility resource indicators: data collection time | Projected vs actual data collection time | Through study completion, an average of 6-months |
| Feasibility resource indicators: data collection completion | Percent missing data | Through study completion, an average of 6-months |
| Feasibility management indicators: Intervention fidelity | Within session effort scores | Through study completion, an average of 6-months |
| Feasibility management indicators: Intervention fidelity/contamination | Video sessions every 2 weeks to assess session content: (i) STRONG group: 1RM lower limb strength progression; (ii) FAST group: Session content via Motor Learning Strategy Rating Instrument (MLSRI) | Through study completion, an average of 6-months |
| Feasibility management indicators: Intervention fidelity | Completion of diaries for motor imagery/strength home practice | Through study completion, an average of 6-months |
| Feasibility management indicators: Intervention fidelity/contamination | Log books for PA-participation tracking/management in active intervention and 4 month follow-up | Through study completion, an average of 6-months |
| Feasibility management indicators:Treatment administration | PTA/RKin session summary form data | Through study completion, an average of 6-months |
| Feasibility management indicators: Acceptability of intervention | Aggregate score of: Parent/staff satisfaction scale, child Physical Activity Enjoyment Scale (PACES), child intervention satisfaction score | Through study completion, an average of 6-months |
| Feasibility science indicators | Treatment response | Through study completion, an average of 6-months |
| Feasibility science indicators:adverse events | Number of adverse events | Through study completion, an average of 6-months |