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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Functional gait-related training

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional gait-related training

Arm Description

16 session, 6-week intensive functional gait-related training intervention based on motor learning principles that includes a motor imagery practice component.

Outcomes

Primary Outcome Measures

Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)

Change from baseline in advanced motor skills on the Challenge Module

The Challenge Module is a new published measure of advanced motor skills.

Secondary Outcome Measures

Change from baseline in resting state activity, assessed using resting state fMRI

Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)

Change from baseline in Physical Activity self-efficacy

Participant-report measure of Task efficacy and Barrier efficacy for physical activity.

Change from baseline in walking activity, assessed using a StepWatch accelerometer

Participants will wear the StepWatch for 5 days.

Change from baseline in gait kinematics as measured using an electronic walkway

Time/distance parameters of footsteps via GAITRite system.

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.

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.

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.

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

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

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

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

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)

Mental chronometry: walking

Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.

Full Information

NCT ID

NCT02584491

First Posted

September 17, 2015

Last Updated

January 15, 2019

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Collaborators

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT02584491

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Collaborators

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Functional gait-related training

Arm Type

Experimental

Arm Description

16 session, 6-week intensive functional gait-related training intervention based on motor learning principles that includes a motor imagery practice component.

Intervention Type

Behavioral

Intervention Name(s)

Functional gait-related training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

Change from baseline in advanced motor skills on the Challenge Module

Description

The Challenge Module is a new published measure of advanced motor skills.

Time Frame

7 days pre/7 days post/4-months post training intervention

Secondary Outcome Measure Information:

Title

Change from baseline in resting state activity, assessed using resting state fMRI

Time Frame

7 days pre/7 days post training intervention

Title

Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)

Time Frame

7 days pre/7 days post training intervention

Title

Change from baseline in Physical Activity self-efficacy

Description

Participant-report measure of Task efficacy and Barrier efficacy for physical activity.

Time Frame