Skip to main content
OpenTrials
Completed

NCT Number: NCT02754128

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

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.

Completed

Looking for future studies?

Notify Me

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

  • 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.)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 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 resting state activity, assessed using resting state fMRI

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

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

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

  4. 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.

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

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

  6. 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.

  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 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

Other outcomes

  1. 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

  2. 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

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

    Time frame: 7 days post training intervention

    Participants' enjoyment of the intervention program will be assessed following the intervention

  4. Intervention session enjoyment

    Time frame: 16 times over 6 weeks (following each intervention session)

    Participants' enjoyment of each session will be assessed using a study-specific questionnaire

  5. Rating of exertion, assessed using Pictorial 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

  6. Heart rate (beats per minute)

    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 staff member via radial pulse.

  7. 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)

  8. Parent Satisfaction scale

    Time frame: 7 days post training intervention

    Parent's satisfaction and perceived benefit of intervention will be assessed using a study-specific questionnaire

  9. Staff Satisfaction scale

    Time frame: 7 days post training intervention

    Staff satisfaction and perceived benefit of intervention for each child in the study will be assessed using a study-specific questionnaire

  10. Lower limb strength

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

    A 30 second lateral step-up test will be used bilaterally to assess functional lower limb strength

  11. Ankle range of motion and dorsiflexion force

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

    Passive and active ROM will be assessed using a goniometer

  12. Dorsiflexion force

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

    Dorsiflexion force will be assessed using surface electromyography (EMG)

  13. Change from baseline in lower-limb proprioception

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

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

  14. Mental chronometry

    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.

  15. Motor Imagery Questionnaire for Children (MIQ-C)

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

    Participant's motor imagery ability will be assessed using the 12-item MIQ-C

  16. Feasibility process indicators: recruitment rate

    Time frame: Through study completion, an average of 6-months

    Recruitment rate: # eligible participants as compared to # screened and # enrolled

  17. Feasibility process indicators: perceived intervention benefit

    Time frame: Through study completion, an average of 6-months

    Perceived intervention benefit calculated as combined child/parent rating

  18. Feasibility process indicators: retention rate

    Time frame: Through study completion, an average of 6-months

    Number of children enrolled as compared to number of children who complete the study

  19. Feasibility resource indicators: adherence rate

    Time frame: Through study completion, an average of 6-months

    Number of sessions completed

  20. Feasibility resource indicators: data collection time

    Time frame: Through study completion, an average of 6-months

    Projected vs actual data collection time

  21. Feasibility resource indicators: data collection completion

    Time frame: Through study completion, an average of 6-months

    Percent missing data

  22. Feasibility management indicators: Intervention fidelity

    Time frame: Through study completion, an average of 6-months

    Within session effort scores

  23. Feasibility management indicators: Intervention fidelity/contamination

    Time frame: Through study completion, an average of 6-months

    Video sessions every 2 weeks to assess session content: (i) STRONG group: 1RM lower limb strength progression; (ii) FAST group: Session content via Motor Learning Strategy Rating Instrument (MLSRI)

  24. Feasibility management indicators: Intervention fidelity

    Time frame: Through study completion, an average of 6-months

    Completion of diaries for motor imagery/strength home practice

  25. Feasibility management indicators: Intervention fidelity/contamination

    Time frame: Through study completion, an average of 6-months

    Log books for PA-participation tracking/management in active intervention and 4 month follow-up

  26. Feasibility management indicators:Treatment administration

    Time frame: Through study completion, an average of 6-months

    PTA/RKin session summary form data

  27. Feasibility management indicators: Acceptability of intervention

    Time frame: Through study completion, an average of 6-months

    Aggregate score of: Parent/staff satisfaction scale, child Physical Activity Enjoyment Scale (PACES), child intervention satisfaction score

  28. Feasibility science indicators

    Time frame: Through study completion, an average of 6-months

    Treatment response

  29. Feasibility science indicators:adverse events

    Time frame: Through study completion, an average of 6-months

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Collaborators

  • The Hospital for Sick Children
  • University of Toronto

Registry information

Official study title

Linking Neuroplasticity With the Outcomes of Walking-based Interventions: A Feasibility Trial Comparing a Motor Learning Versus a Strength-based Program in Children With Cerebral Palsy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
Jan 16, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.