Brain Change After Fun, Athletic, Sports-skill Training (BeFAST) (BeFAST)

Linking Neuroplasticity With the Outcomes of Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Functional gait-related training

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 1R8
      • Holland Bloorview Kids Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Functional gait-related training; The motor learning (ML)-based functional 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. Scheduling flexibility will promote adherence, with a minimum one day between sessions to provide opportunity for rest. 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 active/imagery) will be five per week.

What is the study measuring?

Primary 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)		7 days pre/7 days post training intervention
Change from baseline in advanced motor skills on the Challenge Module	The Challenge Module is a new published measure of advanced motor skills.	7 days pre/7 days post/4-months post training intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in resting state activity, assessed using resting state fMRI		7 days pre/7 days post training intervention
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	Participant-report measure of Task efficacy and Barrier efficacy for physical activity.	7 days pre/7days post/4-months post training intervention
Change from baseline in walking activity, assessed using a StepWatch accelerometer	Participants will wear the StepWatch for 5 days.	7 days pre/7days post/4-months post training intervention
Change from baseline in gait kinematics as measured using an electronic walkway	Time/distance parameters of footsteps via GAITRite system.	7 days pre/7days post/4-months post training intervention
Change from baseline in gait kinetics/kinematics as measured using 3D motion capture system	Whole body gait analysis via Vicon motion capture and Bertec force plates.	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)	Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting.	7 days pre/7days post/4-months post training intervention
Change from baseline in walk speed on the Six-minute walk test	Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.	7 days pre/7days post/4-months post training intervention
Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure	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	7 days pre/7days post/4-months post training intervention
Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)	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	7 days pre/7days post/4-months post training intervention
Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)	The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session	Week 2, 4, 6
Motor learning as evaluated using retention and transfer tests	Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning	Week 2, 4, 6
Change from baseline in lower-limb proprioception	Lower limb joint-sense position and kinesthesia will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)	7 days pre/7days post/4-months post intervention
Mental chronometry: walking	Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.	7 days pre/7days post/4-months post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Pain	Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other)	Completed 2 minutes before and 2 minutes after each intervention session
Intervention enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)	Participants' enjoyment of the intervention sessions will be assessed every 2 weeks, with the questionnaire administered by a research team member not involved in intervention delivery.	Week 2, 4, 6
Rating of exertion, assessed using Pictoral Children's Effort Rating Table (PCERT)	Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion	Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session
Heart Rate	Heart rate will be monitored by treating kinesiologist.	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.

Collaborators and Investigators

• Sponsor: Holland Bloorview Kids Rehabilitation Hospital
• Collaborators: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 14-519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No