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

H

Holland Bloorview Kids Rehabilitation Hospital

Status

Completed

Conditions

Cerebral Palsy

Treatments

Behavioral: BeSTRONG
Behavioral: BeFAST

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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