BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait
- Conditions
- Cerebral Palsy
- Interventions
- Behavioral: BeFASTBehavioral: BeSTRONG
- Registration Number
- NCT02754128
- Lead Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BeFAST BeFAST Motor learning-based program involving athletic lower extremity training of gait-related skills. BeSTRONG BeSTRONG Lower limb strength training program involving progressive muscle resistance exercises.
- Primary Outcome Measures
Name Time Method Change from baseline in advanced motor skills on the Challenge Module 7 days pre/7 days post/4-months post training intervention The Challenge Module is a new published measure of advanced motor skills.
- Secondary Outcome Measures
Name Time Method Change from baseline in walk speed on the Six-minute walk test 7 days pre/7days post/4-months post training intervention Standardized 6 minute walk test (with shoes, orthoses as required) to determine distance covered (capability measure). Well-validated in pediatric CP.
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 7 days pre/7days post/4-months post training intervention Participant-report measure of Task efficacy and Barrier efficacy for physical activity.
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 gait kinematics as measured using an electronic walkway 7 days pre/7days post/4-months post training intervention Time/distance parameters of footsteps via GAITRite system.
Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure 7 days pre/7days post/4-months post training intervention 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
Change from baseline in resting state activity, assessed using resting state fMRI 7 days pre/7 days 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 physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY) 7 days pre/7days post/4-months post training intervention Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting.
Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) 7 days pre/7days post/4-months post training intervention 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
Trial Locations
- Locations (1)
Holland Bloorview Kids Rehabilitation Hospital
🇨🇦Toronto, Ontario, Canada