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

NCT ID: NCT02584491

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional gait-related training

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

Group Type: EXPERIMENTAL

Functional gait-related training

Intervention Type: 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.

Interventions

Functional gait-related training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36524254 (View on PubMed)

Other Identifiers

14-519

Identifier Type: -

Identifier Source: org_study_id