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Completed

NCT Number: NCT02584491

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Change from baseline in advanced motor skills on the Challenge Module

    Time frame: 7 days pre/7 days post/4-months post training intervention

    The Challenge Module is a new published measure of advanced motor skills.

Secondary outcomes

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

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

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

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

  3. Change from baseline in Physical Activity self-efficacy

    Time frame: 7 days pre/7days post/4-months post training intervention

    Participant-report measure of Task efficacy and Barrier efficacy for physical activity.

  4. Change from baseline in walking activity, assessed using a StepWatch accelerometer

    Time frame: 7 days pre/7days post/4-months post training intervention

    Participants will wear the StepWatch for 5 days.

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

    Time frame: 7 days pre/7days post/4-months post training intervention

    Time/distance parameters of footsteps via GAITRite system.

  6. Change from baseline in gait kinetics/kinematics as measured using 3D motion capture system

    Time frame: 7 days pre/7days post/4-months post training intervention

    Whole body gait analysis via Vicon motion capture and Bertec force plates.

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

    Time frame: 7 days pre/7days post/4-months post training intervention

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

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

    Time frame: 7 days pre/7days post/4-months post training intervention

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

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

    Time frame: 7 days pre/7days post/4-months post training intervention

    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

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

    Time frame: 7 days pre/7days post/4-months post training intervention

    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

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

    Time frame: Week 2, 4, 6

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

  12. Motor learning as evaluated using retention and transfer tests

    Time frame: Week 2, 4, 6

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

  13. Change from baseline in lower-limb proprioception

    Time frame: 7 days pre/7days post/4-months post intervention

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

  14. Mental chronometry: walking

    Time frame: 7 days pre/7days post/4-months post intervention

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

Other outcomes

  1. Body Pain

    Time frame: Completed 2 minutes before and 2 minutes after each intervention session

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

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

    Time frame: Week 2, 4, 6

    Participants' enjoyment of the intervention sessions will be assessed every 2 weeks, with the questionnaire administered by a research team member not involved in intervention delivery.

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

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

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

  4. Heart Rate

    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.

    Heart rate will be monitored by treating kinesiologist.

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

Linking Neuroplasticity With the Outcomes of Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth With Cerebral Palsy

Acronym: BeFAST

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2015
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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