Clinical trial NCT02584491: Brain Change After Fun, Athletic, Sports-skill Training (BeFAST)
Official title: Linking Neuroplasticity With the Outcomes of Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth 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
First posted: 2015-10-22
Enrollment: 9
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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 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).

Primary 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 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 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 a StepWatch 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 gait kinetics/kinematics as measured using 3D motion capture system
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
measure: Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)
timeFrame: Week 2, 4, 6
measure: Motor learning as evaluated using retention and transfer tests
timeFrame: Week 2, 4, 6
measure: Change from baseline in lower-limb proprioception
timeFrame: 7 days pre/7days post/4-months post intervention
measure: Mental chronometry: walking
timeFrame: 7 days pre/7days post/4-months post intervention
Other outcomes:
measure: Body Pain
timeFrame: Completed 2 minutes before and 2 minutes after each intervention session
measure: Intervention enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)
timeFrame: Week 2, 4, 6
measure: Rating of exertion, assessed using Pictoral 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
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.
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
References: