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

NCT02754128 | Completed

• 1 other identifier: 16-624
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 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

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

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

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

Other Outcomes (29)

• Motor learning as evaluated using retention and transfer tests

  Week 2, 4, 6

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

  Week 2, 4, 6

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

  7 days post training intervention

Study Arms (2)

BeFAST

ACTIVE COMPARATOR

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

Behavioral: BeFAST

BeSTRONG

ACTIVE COMPARATOR

Lower limb strength training program involving progressive muscle resistance exercises.

Behavioral: BeSTRONG

Interventions

BeFAST BEHAVIORAL

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.

BeFAST

BeSTRONG BEHAVIORAL

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.

BeSTRONG

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• Hilderley AJ, Wright FV, Taylor MJ, Chen JL, Fehlings D. Functional Neuroplasticity and Motor Skill Change Following Gross Motor Interventions for Children With Diplegic Cerebral Palsy. Neurorehabil Neural Repair. 2023 Jan;37(1):16-26. doi: 10.1177/15459683221143503. Epub 2022 Dec 15.

  PMID: 36524254 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Virginia Wright

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 28, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 16, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)