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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754128
• Other study ID #: 16-624
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• BeFAST
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
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	The Hospital for Sick Children, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Intervention program enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES)	Participants' enjoyment of the intervention program will be assessed following the intervention	7 days post training intervention
Other	Intervention session enjoyment	Participants' enjoyment of each session will be assessed using a study-specific questionnaire	16 times over 6 weeks (following each intervention session)
Other	Rating of exertion, assessed using Pictorial 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 (beats per minute)	Heart rate will be monitored by treating staff member via radial pulse.	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
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	Parent Satisfaction scale	Parent's satisfaction and perceived benefit of intervention will be assessed using a study-specific questionnaire	7 days post training intervention
Other	Staff Satisfaction scale	Staff satisfaction and perceived benefit of intervention for each child in the study will be assessed using a study-specific questionnaire	7 days post training intervention
Other	Lower limb strength	A 30 second lateral step-up test will be used bilaterally to assess functional lower limb strength	7 days pre/7days post/4-months post intervention
Other	Ankle range of motion and dorsiflexion force	Passive and active ROM will be assessed using a goniometer	7 days pre/7days post/4-months post intervention
Other	Dorsiflexion force	Dorsiflexion force will be assessed using surface electromyography (EMG)	7 days pre/7days post/4-months post intervention
Other	Change from baseline in lower-limb proprioception	Lower limb joint-sense position will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009)	7 days pre/7days post/4-months post intervention
Other	Mental chronometry	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
Other	Motor Imagery Questionnaire for Children (MIQ-C)	Participant's motor imagery ability will be assessed using the 12-item MIQ-C	7 days pre/7days post/4-months post intervention
Other	Feasibility process indicators: recruitment rate	Recruitment rate: # eligible participants as compared to # screened and # enrolled	Through study completion, an average of 6-months
Other	Feasibility process indicators: perceived intervention benefit	Perceived intervention benefit calculated as combined child/parent rating	Through study completion, an average of 6-months
Other	Feasibility process indicators: retention rate	Number of children enrolled as compared to number of children who complete the study	Through study completion, an average of 6-months
Other	Feasibility resource indicators: adherence rate	Number of sessions completed	Through study completion, an average of 6-months
Other	Feasibility resource indicators: data collection time	Projected vs actual data collection time	Through study completion, an average of 6-months
Other	Feasibility resource indicators: data collection completion	Percent missing data	Through study completion, an average of 6-months
Other	Feasibility management indicators: Intervention fidelity	Within session effort scores	Through study completion, an average of 6-months
Other	Feasibility management indicators: Intervention fidelity/contamination	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)	Through study completion, an average of 6-months
Other	Feasibility management indicators: Intervention fidelity	Completion of diaries for motor imagery/strength home practice	Through study completion, an average of 6-months
Other	Feasibility management indicators: Intervention fidelity/contamination	Log books for PA-participation tracking/management in active intervention and 4 month follow-up	Through study completion, an average of 6-months
Other	Feasibility management indicators:Treatment administration	PTA/RKin session summary form data	Through study completion, an average of 6-months
Other	Feasibility management indicators: Acceptability of intervention	Aggregate score of: Parent/staff satisfaction scale, child Physical Activity Enjoyment Scale (PACES), child intervention satisfaction score	Through study completion, an average of 6-months
Other	Feasibility science indicators	Treatment response	Through study completion, an average of 6-months
Other	Feasibility science indicators:adverse events	Number of adverse events	Through study completion, an average of 6-months
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 functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)		7 days pre/7 days 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 an Actigraph accelerometer		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 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 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