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

Cerebral Palsy Clinical Trial

— BeFAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584491
• Other study ID #: 14-519
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Pain	Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other)	Completed 2 minutes before and 2 minutes after each intervention session
Other	Intervention enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)	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.	Week 2, 4, 6
Other	Rating of exertion, assessed using Pictoral Children's Effort Rating Table (PCERT)	Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion	Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session
Other	Heart Rate	Heart rate will be monitored by treating kinesiologist.	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.
Primary	Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)		7 days pre/7 days post training intervention
Primary	Change from baseline in advanced motor skills on the Challenge Module	The Challenge Module is a new published measure of advanced motor skills.	7 days pre/7 days post/4-months post training intervention
Secondary	Change from baseline in resting state activity, assessed using resting state fMRI		7 days pre/7 days post training intervention
Secondary	Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)		7 days pre/7 days post training intervention
Secondary	Change from baseline in Physical Activity self-efficacy	Participant-report measure of Task efficacy and Barrier efficacy for physical activity.	7 days pre/7days post/4-months post training intervention
Secondary	Change from baseline in walking activity, assessed using a StepWatch accelerometer	Participants will wear the StepWatch for 5 days.	7 days pre/7days post/4-months post training intervention
Secondary	Change from baseline in gait kinematics as measured using an electronic walkway	Time/distance parameters of footsteps via GAITRite system.	7 days pre/7days post/4-months post training intervention
Secondary	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.	7 days pre/7days post/4-months post training intervention
Secondary	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.	7 days pre/7days post/4-months post training intervention
Secondary	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.	7 days pre/7days post/4-months post training intervention
Secondary	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	7 days pre/7days post/4-months post training intervention
Secondary	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	7 days pre/7days post/4-months post training intervention
Secondary	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	Week 2, 4, 6
Secondary	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	Week 2, 4, 6
Secondary	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)	7 days pre/7days post/4-months post intervention
Secondary	Mental chronometry: walking	Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance.	7 days pre/7days post/4-months post intervention