- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754128
BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: BeFAST
Motor learning-based program involving athletic lower extremity training of gait-related skills.
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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.
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ACTIVE_COMPARATOR: BeSTRONG
Lower limb strength training program involving progressive muscle resistance exercises.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in advanced motor skills on the Challenge Module
Time Frame: 7 days pre/7 days post/4-months post training intervention
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The Challenge Module is a new published measure of advanced motor skills.
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7 days pre/7 days post/4-months post training intervention
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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)
Time Frame: 7 days pre/7 days post training intervention
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7 days pre/7 days post training intervention
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Change from baseline in resting state activity, assessed using resting state fMRI
Time Frame: 7 days pre/7 days post training intervention
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7 days pre/7 days post training intervention
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Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)
Time Frame: 7 days pre/7 days post training intervention
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7 days pre/7 days post training intervention
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Change from baseline in Physical Activity self-efficacy
Time Frame: 7 days pre/7days post/4-months post training intervention
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Participant-report measure of Task efficacy and Barrier efficacy for physical activity.
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7 days pre/7days post/4-months post training intervention
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Change from baseline in gait kinematics as measured using an electronic walkway
Time Frame: 7 days pre/7days post/4-months post training intervention
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Time/distance parameters of footsteps via GAITRite system.
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7 days pre/7days post/4-months post training intervention
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Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY)
Time Frame: 7 days pre/7days post/4-months post training intervention
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Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting.
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7 days pre/7days post/4-months post training intervention
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Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure
Time Frame: 7 days pre/7days post/4-months post training intervention
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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
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7 days pre/7days post/4-months post training intervention
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Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)
Time Frame: 7 days pre/7days post/4-months post training intervention
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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
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7 days pre/7days post/4-months post training intervention
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Change from baseline in walking activity, assessed using an Actigraph accelerometer
Time Frame: 7 days pre/7days post/4-months post training intervention
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7 days pre/7days post/4-months post training intervention
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Change from baseline in walk speed on the Six-minute walk test
Time Frame: 7 days pre/7days post/4-months post training intervention
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Standardized 6 minute walk test (with shoes, orthoses as required) to determine distance covered (capability measure).
Well-validated in pediatric CP.
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7 days pre/7days post/4-months post training intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)
Time Frame: Week 2, 4, 6
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The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session
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Week 2, 4, 6
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Motor learning as evaluated using retention and transfer tests
Time Frame: Week 2, 4, 6
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Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning
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Week 2, 4, 6
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Intervention program enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)
Time Frame: 7 days post training intervention
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Participants' enjoyment of the intervention program will be assessed following the intervention
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7 days post training intervention
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Intervention session enjoyment
Time Frame: 16 times over 6 weeks (following each intervention session)
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Participants' enjoyment of each session will be assessed using a study-specific questionnaire
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16 times over 6 weeks (following each intervention session)
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Rating of exertion, assessed using Pictorial Children's Effort Rating Table (PCERT)
Time Frame: Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session
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Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion
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Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session
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Heart rate (beats per minute)
Time Frame: 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
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Heart rate will be monitored by treating staff member via radial pulse.
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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
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Body pain
Time Frame: Completed 2 minutes before and 2 minutes after each intervention session
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Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other)
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Completed 2 minutes before and 2 minutes after each intervention session
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Parent Satisfaction scale
Time Frame: 7 days post training intervention
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Parent's satisfaction and perceived benefit of intervention will be assessed using a study-specific questionnaire
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7 days post training intervention
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Staff Satisfaction scale
Time Frame: 7 days post training intervention
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Staff satisfaction and perceived benefit of intervention for each child in the study will be assessed using a study-specific questionnaire
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7 days post training intervention
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Lower limb strength
Time Frame: 7 days pre/7days post/4-months post intervention
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A 30 second lateral step-up test will be used bilaterally to assess functional lower limb strength
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7 days pre/7days post/4-months post intervention
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Ankle range of motion and dorsiflexion force
Time Frame: 7 days pre/7days post/4-months post intervention
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Passive and active ROM will be assessed using a goniometer
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7 days pre/7days post/4-months post intervention
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Dorsiflexion force
Time Frame: 7 days pre/7days post/4-months post intervention
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Dorsiflexion force will be assessed using surface electromyography (EMG)
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7 days pre/7days post/4-months post intervention
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Change from baseline in lower-limb proprioception
Time Frame: 7 days pre/7days post/4-months post intervention
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Lower limb joint-sense position will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)
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7 days pre/7days post/4-months post intervention
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Mental chronometry
Time Frame: 7 days pre/7days post/4-months post intervention
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Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.
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7 days pre/7days post/4-months post intervention
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Motor Imagery Questionnaire for Children (MIQ-C)
Time Frame: 7 days pre/7days post/4-months post intervention
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Participant's motor imagery ability will be assessed using the 12-item MIQ-C
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7 days pre/7days post/4-months post intervention
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Feasibility process indicators: recruitment rate
Time Frame: Through study completion, an average of 6-months
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Recruitment rate: # eligible participants as compared to # screened and # enrolled
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Through study completion, an average of 6-months
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Feasibility process indicators: perceived intervention benefit
Time Frame: Through study completion, an average of 6-months
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Perceived intervention benefit calculated as combined child/parent rating
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Through study completion, an average of 6-months
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Feasibility process indicators: retention rate
Time Frame: Through study completion, an average of 6-months
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Number of children enrolled as compared to number of children who complete the study
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Through study completion, an average of 6-months
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Feasibility resource indicators: adherence rate
Time Frame: Through study completion, an average of 6-months
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Number of sessions completed
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Through study completion, an average of 6-months
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Feasibility resource indicators: data collection time
Time Frame: Through study completion, an average of 6-months
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Projected vs actual data collection time
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Through study completion, an average of 6-months
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Feasibility resource indicators: data collection completion
Time Frame: Through study completion, an average of 6-months
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Percent missing data
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Through study completion, an average of 6-months
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Feasibility management indicators: Intervention fidelity
Time Frame: Through study completion, an average of 6-months
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Within session effort scores
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Through study completion, an average of 6-months
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Feasibility management indicators: Intervention fidelity/contamination
Time Frame: Through study completion, an average of 6-months
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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)
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Through study completion, an average of 6-months
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Feasibility management indicators: Intervention fidelity
Time Frame: Through study completion, an average of 6-months
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Completion of diaries for motor imagery/strength home practice
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Through study completion, an average of 6-months
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Feasibility management indicators: Intervention fidelity/contamination
Time Frame: Through study completion, an average of 6-months
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Log books for PA-participation tracking/management in active intervention and 4 month follow-up
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Through study completion, an average of 6-months
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Feasibility management indicators:Treatment administration
Time Frame: Through study completion, an average of 6-months
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PTA/RKin session summary form data
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Through study completion, an average of 6-months
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Feasibility management indicators: Acceptability of intervention
Time Frame: Through study completion, an average of 6-months
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Aggregate score of: Parent/staff satisfaction scale, child Physical Activity Enjoyment Scale (PACES), child intervention satisfaction score
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Through study completion, an average of 6-months
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Feasibility science indicators
Time Frame: Through study completion, an average of 6-months
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Treatment response
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Through study completion, an average of 6-months
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Feasibility science indicators:adverse events
Time Frame: Through study completion, an average of 6-months
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Number of adverse events
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Through study completion, an average of 6-months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-624
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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