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

Holland Bloorview Kids Rehabilitation Hospital

Status: Completed

Conditions: Cerebral Palsy

Treatments: Behavioral: BeFAST; Behavioral: BeSTRONG

Study type: Interventional

Funder types: Other

Identifiers

NCT02754128

16-624

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

BeFAST

Active Comparator group

Description:

Motor learning-based program involving athletic lower extremity training of gait-related skills.

Treatment:

Behavioral: BeFAST

BeSTRONG

Active Comparator group

Description:

Lower limb strength training program involving progressive muscle resistance exercises.

Treatment:

Behavioral: BeSTRONG