None listed
Conditions
Brief summary
Children with cerebral palsy (CP) have difficulty with mobility due to increased muscle tone (spasticity) and weakness in their legs. In recent years, botulinum toxin type A (BoNT-A, or botox) has been used to treat muscle spasticity, providing an opportunity for physiotherapy to improve walking ability and endurance. Current research findings suggest that the effect of botox can be increased by making sure that injected muscles are actively contracting at the time of injection. If this theory is correct, strategies which “activate” the injected muscle may play a vital role in making the most of a given botox treatment. This project will test this theory by comparing 2 groups of children who receive botox; one group will also receive electrical stimulation to the affected calf muscle at the time of the botox injection, and the other group will only receive the injection. Both groups will then receive standard post-injection physiotherapy. The two groups will then have their walking ability assessed using specialised gait analysis. This project has the potential to improve the effects of botox treatment for all children who are injected.
Interventions
The intervention being studied is electrical stimulation, as provided by a commercially available functional electrical stimulation (FES) device. The intervention group receives stimulation pre-botox (in theatre, applied directly to the gastrocnemius muscle via an insulated surgical needle, for 2 minutes) and then post-injection over the next 2 days (one 30 min session that evening, three 30 min sessions the following day, and three 30 min sessions on day two - seven 30 min stimulation sessions
The intervention being studied is electrical stimulation, as provided by a commercially available functional electrical stimulation (FES) device. The intervention group receives stimulation pre-botox (in theatre, applied directly to the gastrocnemius muscle via an insulated surgical needle, for 2 minutes) and then post-injection over the next 2 days (one 30 min session that evening, three 30 min sessions the following day, and three 30 min sessions on day two - seven 30 min stimulation sessions in total). Standard botox dosing is used (in the range of 3-6 units per kilogram) and every subject receives routine physiotherapy post-botox.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Healthy volunteers
Yes
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
Outcome results
None listed