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BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

BeFAST

BeSTRONG

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:

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.)

Sites / Locations

Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

BeFAST

BeSTRONG

Arm Description

Motor learning-based program involving athletic lower extremity training of gait-related skills.

Lower limb strength training program involving progressive muscle resistance exercises.

Outcomes

Primary Outcome Measures

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

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 an Actigraph accelerometer

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

Time/distance parameters of footsteps via GAITRite system.

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 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

Full Information

NCT ID

NCT02754128

First Posted

April 6, 2016

Last Updated

January 15, 2019

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Collaborators

The Hospital for Sick Children, University of Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02754128

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (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, University of Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BeFAST

Arm Type

Active Comparator

Arm Description

Motor learning-based program involving athletic lower extremity training of gait-related skills.

Arm Title

BeSTRONG

Arm Type

Active Comparator

Arm Description

Lower limb strength training program involving progressive muscle resistance exercises.

Intervention Type

Behavioral

Intervention Name(s)

BeFAST

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BeSTRONG

Intervention Description

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.

Primary Outcome Measure Information:

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 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 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

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

Title

Change from baseline in walking activity, assessed using an Actigraph accelerometer

Time Frame

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

Title

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

Description

Time/distance parameters of footsteps via GAITRite system.

Time Frame

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

Title

Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY)

Description

Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting.

Time Frame

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

Title

Change from baseline in walk speed on the Six-minute walk test

Description

Standardized 6 minute walk test (with shoes, orthoses as required) to determine distance covered (capability measure). Well-validated in pediatric CP.

Time Frame

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

Title

Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure

Description

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

Time Frame

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

Title

Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Motor learning as evaluated using retention and transfer tests

Description

Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning

Time Frame

Week 2, 4, 6

Title

Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)

Description

The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session

Time Frame

Week 2, 4, 6

Title

Intervention program enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)

Description

Participants' enjoyment of the intervention program will be assessed following the intervention

Time Frame

7 days post training intervention

Title

Intervention session enjoyment

Description

Participants' enjoyment of each session will be assessed using a study-specific questionnaire

Time Frame

16 times over 6 weeks (following each intervention session)

Title

Rating of exertion, assessed using Pictorial Children's Effort Rating Table (PCERT)

Description

Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion

Time Frame

Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session

Title

Heart rate (beats per minute)

Description

Heart rate will be monitored by treating staff member via radial pulse.

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

Title

Body pain

Description

Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other)

Time Frame

Completed 2 minutes before and 2 minutes after each intervention session

Title

Parent Satisfaction scale

Description

Parent's satisfaction and perceived benefit of intervention will be assessed using a study-specific questionnaire

Time Frame

7 days post training intervention

Title

Staff Satisfaction scale

Description

Staff satisfaction and perceived benefit of intervention for each child in the study will be assessed using a study-specific questionnaire

Time Frame

7 days post training intervention

Title

Lower limb strength

Description

A 30 second lateral step-up test will be used bilaterally to assess functional lower limb strength

Time Frame

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

Title

Ankle range of motion and dorsiflexion force

Description

Passive and active ROM will be assessed using a goniometer

Time Frame

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

Title

Dorsiflexion force

Description

Dorsiflexion force will be assessed using surface electromyography (EMG)

Time Frame

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

Title

Change from baseline in lower-limb proprioception

Description

Lower limb joint-sense position will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)

Time Frame

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

Title

Mental chronometry

Description

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

Time Frame

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

Title

Motor Imagery Questionnaire for Children (MIQ-C)

Description

Participant's motor imagery ability will be assessed using the 12-item MIQ-C

Time Frame

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

Title

Feasibility process indicators: recruitment rate

Description

Recruitment rate: # eligible participants as compared to # screened and # enrolled

Time Frame