Cerebral PalsyNCT02754128
BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait
A study testing BeFAST and BeSTRONG in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- BeFAST and BeSTRONG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
Official 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
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
- Being tested
- BeFAST, BeSTRONG
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeFASTBehavioural
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.
BeSTRONGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BeFAST | Active comparator | Motor learning-based program involving athletic lower extremity training of gait-related skills. Receives: Behavioral: BeFAST |
| BeSTRONG | Active comparator | Lower limb strength training program involving progressive muscle resistance exercises. Receives: Behavioral: BeSTRONG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in advanced motor skills on the Challenge Module
The Challenge Module is a new published measure of advanced motor skills.
Measured: 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)
Measured: 7 days pre/7 days post training intervention
Change from baseline in resting state activity, assessed using resting state fMRI
Measured: 7 days pre/7 days post training intervention
Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)
Measured: 7 days pre/7 days post training intervention
Change from baseline in Physical Activity self-efficacy
Participant-report measure of Task efficacy and Barrier efficacy for physical activity.
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in walking activity, assessed using an Actigraph accelerometer
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in gait kinematics as measured using an electronic walkway
Time/distance parameters of footsteps via GAITRite system.
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY)
Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting.
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in walk speed on the Six-minute walk test
Standardized 6 minute walk test (with shoes, orthoses as required) to determine distance covered (capability measure). Well-validated in pediatric CP.
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure
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
Measured: 7 days pre/7days post/4-months post training intervention
Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)
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
Measured: 7 days pre/7days post/4-months post training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Virginia Wright, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754128
- Sponsor's protocol ID
- 16-624
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36524254
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02754128
- Acronym / sponsor ID
- 16-624
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Study start
- Jun 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BeFAST | Active comparator | Behavioral: BeFASTMotor learning-based program involving athletic lower extremity training of gait-related skills. |
| BeSTRONG | Active comparator | Behavioral: BeSTRONGLower limb strength training program involving progressive muscle resistance exercises. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeFASTThe 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. | Behavioural | BeFAST |
| BeSTRONGThe 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. | Behavioural | BeSTRONG |
Primary outcome
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.
10 secondary outcomes
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
Change from baseline in resting state activity, assessed using resting state fMRI
Time frame: 7 days pre/7 days post training intervention
Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)
Time frame: 7 days pre/7 days post training intervention
Change from baseline in Physical Activity self-efficacy
Time frame: 7 days pre/7days post/4-months post training intervention
Change from baseline in walking activity, assessed using an Actigraph accelerometer
Time frame: 7 days pre/7days post/4-months post training intervention
Change from baseline in gait kinematics as measured using an electronic walkway
Time frame: 7 days pre/7days post/4-months post training intervention
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
Change from baseline in walk speed on the Six-minute walk test
Time frame: 7 days pre/7days post/4-months post training intervention
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 36524254Hilderley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Wright principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeFAST and BeSTRONG in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in advanced motor skills on the Challenge Module (time frame: 7 days pre/7 days post/4-months post training intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.