Cerebral PalsyBeFASTNCT02584491
Brain Change After Fun, Athletic, Sports-skill Training (BeFAST)
A study testing Functional gait-related training 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 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… 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?
- Functional gait-related training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Dec 2016
- 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
- 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.
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 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).
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 Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth With Cerebral Palsy
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
- Being tested
- Functional gait-related training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional gait-related trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Functional gait-related training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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 (14)
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 a StepWatch accelerometer
Participants will wear the StepWatch for 5 days.
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 gait kinetics/kinematics as measured using 3D motion capture system
Whole body gait analysis via Vicon motion capture and Bertec force plates.
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, walking devices 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
Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)
The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session
Measured: Week 2, 4, 6
Motor learning as evaluated using retention and transfer tests
Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning
Measured: Week 2, 4, 6
Change from baseline in lower-limb proprioception
Lower limb joint-sense position and kinesthesia will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)
Measured: 7 days pre/7days post/4-months post intervention
Mental chronometry: walking
Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.
Measured: 7 days pre/7days post/4-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584491
- Sponsor's protocol ID
- 14-519
- Acronym
- BeFAST
- Status last verified
- Jan 2019
- First submitted
- 17 Sep 2015
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02584491
- Acronym / sponsor ID
- BeFAST / 14-519
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Oct 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional gait-related training | Experimental | Behavioral: Functional gait-related training16 session, 6-week intensive functional gait-related training intervention based on motor learning principles that includes a motor imagery practice component. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
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 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);
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 |
|---|---|---|
| Functional gait-related trainingThe 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. | Behavioural | Functional gait-related training |
Primary outcome
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 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.
14 secondary outcomes
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 a StepWatch 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 gait kinetics/kinematics as measured using 3D motion capture system
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
Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)
Time frame: Week 2, 4, 6
Motor learning as evaluated using retention and transfer tests
Time frame: Week 2, 4, 6
Change from baseline in lower-limb proprioception
Time frame: 7 days pre/7days post/4-months post intervention
Mental chronometry: walking
Time frame: 7 days pre/7days post/4-months post 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 17 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional gait-related training 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 6 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 17 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 functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI) (time frame: 7 days pre/7 days post training intervention). The study lists 2 primary outcomes in all. 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 NCT02584491, 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 17 Jan 2019.