Brain Change After Fun, Athletic, Sports-skill Training (BeFAST)
- Conditions
- Cerebral Palsy
- Interventions
- Behavioral: Functional gait-related training
- Registration Number
- NCT02584491
- Lead Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Brief Summary
The purpose of this study is to determine the associations between changes in neural activity and structure, advanced gross motor skills, gait characteristics, and physical activity participation following a gait-related intervention that is based on motor learning principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The investigators' hypothesis is that in conjunction with a program of motor learning based training, functional neuroplastic changes in the involved motor areas will be strongly associated with changes in gait and advanced gross motor skills, moderately associated with physical activity based participation changes, and will have a fair association with structural neuroplastic change.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Age 7 to17 years inclusive;
- GMFCS Level I or II;
- Able to follow testing and motor imagery instructions;
- Able to actively participate in a minimum of 45 minutes of physical activity;
- Able to independently dorsiflex 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 discontinue BTX-A for period of 12 weeks (during trial) due to concerns about ROM or pain;
- Severe spasticity (may be a contraindication for neuroimaging procedures);
- Seizure disorder (if not fully controlled by medication for the 12 months);
- Not prepared or unable to discontinue a regular lower limb therapy intervention during the course of the trial;
- Involved in another intervention study;
- Standard MRI contraindications (e.g., metal implants such as cochlear implant, claustrophobia).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Functional gait-related training Functional gait-related training 16 session, 6-week intensive functional gait-related training intervention based on motor learning principles that includes a motor imagery practice component.
- Primary Outcome Measures
Name Time Method 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 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 resting state activity, assessed using resting state fMRI 7 days pre/7 days post training intervention Mental chronometry: walking 7 days pre/7days post/4-months post intervention Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.
Change from baseline in walking activity, assessed using a StepWatch accelerometer 7 days pre/7days post/4-months post training intervention Participants will wear the StepWatch for 5 days.
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, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.
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
Motor learning as evaluated using retention and transfer tests Week 2, 4, 6 Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning
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.
Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI) Week 2, 4, 6 The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session
Change from baseline in lower-limb proprioception 7 days pre/7days post/4-months post intervention Lower limb joint-sense position and kinesthesia will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)
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 gait kinetics/kinematics as measured using 3D motion capture system 7 days pre/7days post/4-months post training intervention Whole body gait analysis via Vicon motion capture and Bertec force plates.
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