BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait

Study Overview
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Brief Summary
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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.

Official Title
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Linking Neuroplasticity With the Outcomes of Walking-based Interventions: A Feasibility Trial Comparing a Motor Learning Versus a Strength-based Program in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: BeFAST
* Behavioral: BeSTRONG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7-17 years old diagnosis of hemiplegic or diplegic Cerebral Palsy GMFCS Level I-II able to follow testing and motor imagery instructions able to actively participate in a minimum of 45 minutes (min) of physical activity show evidence of independent dorsiflexion of both ankles able to commit to attendance of sessions two to three times weekly for six weeks. Exclusion Criteria: orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months inability to put BTX-A on hold during trial severe spasticity (may be a contraindication for neuroimaging procedures) seizure disorder (if not fully controlled by medication for 12 months) not prepared or unable to discontinue any formal lower limb therapy intervention or physical activity program during the trial involved in another intervention study standard MRI contraindications (e.g., magnetic implants, inability to lay still, claustrophobia etc.)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BeFAST<br>Motor learning-based program involving athletic lower extremity training of gait-related skills. | Behavioral: BeFAST<br>* 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.<br>|
| Active Comparator: BeSTRONG<br>Lower limb strength training program involving progressive muscle resistance exercises. | Behavioral: BeSTRONG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |