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

Holland Bloorview Kids Rehabilitation Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cerebral Palsy

Interventions

BeFAST

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.

BeSTRONGBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Change from baseline in advanced motor skills on the Challenge Module

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 Outcomes

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

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

Time frame: 7 days pre/7 days post training intervention

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

Time frame: 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.