Clinical trial NCT02754128: BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: University of Toronto
First posted: 2016-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Change from baseline in advanced motor skills on the Challenge Module
timeFrame: 7 days pre/7 days post/4-months post training intervention
Secondary outcomes:
measure: Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)
timeFrame: 7 days pre/7 days post training intervention
measure: Change from baseline in resting state activity, assessed using resting state fMRI
timeFrame: 7 days pre/7 days post training intervention
measure: Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)
timeFrame: 7 days pre/7 days post training intervention
measure: Change from baseline in Physical Activity self-efficacy
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in walking activity, assessed using an Actigraph accelerometer
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in gait kinematics as measured using an electronic walkway
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY)
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in walk speed on the Six-minute walk test
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure
timeFrame: 7 days pre/7days post/4-months post training intervention
measure: Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)
timeFrame: 7 days pre/7days post/4-months post training intervention
Other outcomes:
measure: Motor learning as evaluated using retention and transfer tests
timeFrame: Week 2, 4, 6
measure: Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)
timeFrame: Week 2, 4, 6
measure: Intervention program enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)
timeFrame: 7 days post training intervention
measure: Intervention session enjoyment
timeFrame: 16 times over 6 weeks (following each intervention session)
measure: Rating of exertion, assessed using Pictorial Children's Effort Rating Table (PCERT)
timeFrame: Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session
measure: Heart rate (beats per minute)
timeFrame: 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
measure: Body pain
timeFrame: Completed 2 minutes before and 2 minutes after each intervention session
measure: Parent Satisfaction scale
timeFrame: 7 days post training intervention
measure: Staff Satisfaction scale
timeFrame: 7 days post training intervention
measure: Lower limb strength
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Ankle range of motion and dorsiflexion force
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Dorsiflexion force
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Change from baseline in lower-limb proprioception
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Mental chronometry
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Motor Imagery Questionnaire for Children (MIQ-C)
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Feasibility process indicators: recruitment rate
timeFrame: Through study completion, an average of 6-months
measure: Feasibility process indicators: perceived intervention benefit
timeFrame: Through study completion, an average of 6-months
measure: Feasibility process indicators: retention rate
timeFrame: Through study completion, an average of 6-months
measure: Feasibility resource indicators: adherence rate
timeFrame: Through study completion, an average of 6-months
measure: Feasibility resource indicators: data collection time
timeFrame: Through study completion, an average of 6-months
measure: Feasibility resource indicators: data collection completion
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators: Intervention fidelity
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators: Intervention fidelity/contamination
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators: Intervention fidelity
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators: Intervention fidelity/contamination
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators:Treatment administration
timeFrame: Through study completion, an average of 6-months
measure: Feasibility management indicators: Acceptability of intervention
timeFrame: Through study completion, an average of 6-months
measure: Feasibility science indicators
timeFrame: Through study completion, an average of 6-months
measure: Feasibility science indicators:adverse events
timeFrame: Through study completion, an average of 6-months
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Virginia Wright
role: PRINCIPAL_INVESTIGATOR
References: