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

NCT02584491 | Completed

• 1 other identifier: 14-519
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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 a StepWatch accelerometer

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

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

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

Other Outcomes (4)

• Body Pain

  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)

  Week 2, 4, 6

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

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

Study Arms (1)

Functional gait-related training

EXPERIMENTAL

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

Interventions

Functional gait-related training BEHAVIORAL

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.

Functional gait-related training

Eligibility Criteria

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

You may qualify if:

• 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.

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 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).

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• The Hospital for Sick Children: 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: October 22, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

CA (1)