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Clinical rehabilitation · Mar 2005
Randomized Controlled Trial Clinical TrialA randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury.
- D Verplancke, S Snape, C F Salisbury, P W Jones, and A B Ward.
- North Staffordshire Rehabilitation Centre, University Hospital of North Staffordshire NHS Trust, UK.
- Clin Rehabil. 2005 Mar 1; 19 (2): 117-25.
ObjectiveTo determine whether serial casting combined with botulinum toxin reduces the development of calf contracture after severe head injury.DesignA double-blind placebo-controlled trial of three parallel treatments for lower limb spasticity.SettingAcute general hospital in the UK.SubjectsAdults aged 17-70 years admitted to hospital following a severe brainInterventionsCurrent physical treatment (group I), lower leg casting plus injections with either saline (group II), or with botulinum toxin (group III) into gastrocnemius and soleus muscles.MeasuresLimit of ankle dorsiflexion at entry and exit after up to 12 weeks, the Glasgow Outcome Scale (GOS) and Modified Ashworth Scale (MAS).ResultsTwo hundred and fifty-three patients were screened and 35 were entered into the trial. Three patients died and four failed to complete the trial. Eighty-eight per cent of those entering the randomized part of the study developed spasticity within 14 days of their injury and the mean range of improvement in the angle of passive ankle dorsiflexion was 4.59 degrees in controls, 11.69 degrees in cast and saline and 13.59 degrees in cast and botulinum toxin. There were significant improvements in the MAS scores in actively treated groups, but not in controls. Cast and botulinum toxin patients also demonstrated a significant improvement in the GOS.ConclusionsActive intervention with casting prevents talipes equinovarus deformities in patients losing ankle movement following severe brain injury. Casting alone in these patients is sufficient; the role of additional botulinum toxin needs further investigation, but is safe in these patients.
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