Electrical stimulation in botulinum toxin A use in children with cerebral palsy: a randomised trial

Not Applicable

• Conditions: Cerebral palsy, both hemiplegic and diplegic conditions, in children aged 4-12 years old.; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12609000713291
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Children between the ages of 4 and 12 years with a confirmed diagnosis of spastic hemiplegic or spastic diplegic cerebral palsy (CP)
2. Planned injection of gastrocnemius muscle for the treatment of dynamic equinus deformity
3. Walking ability described by classification at Gross Motor Functional Classification System (GMFCS) levels one to three (walks independently or with assistive devices)
4. Ongoing participation in a community-based therapy programme.

Exclusion Criteria

1. Previous lower limb surgery involving the calf and/or hamstring
2. Use of botox A in the calf muscle within the last six months
3. Inability to follow a single stage command
4. Inability to walk along a 10m walk way for a total of five trials
5. Presence of fixed muscle contractures.
6. Casting post-botox injection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the peak dorsiflexion angle in stance phase in the sagittal plane recorded in gait analysis.[3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are: (1) angles of dorsiflexion/plantarflexion at the ankle and knee at initial contact, mid stance, and terminal stance; and[3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.];(2) the modified Ashworth and modified Tardieu scores, both clinical measures of spasticity, as well as the selective motor control score.[3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.]