At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of the Efficacy of the Selective Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patient Following the ICF Model. A Prospective, Randomized, Controlled Single Blind Study
In Brief
A Phase 3 clinical trial evaluating Selective tibial neurotomy and Botulinum toxin injection for Spastic Equinovarus Foot and Stroke. Completed, enrolled 16 participants across 1 site.
Detailed Summary
Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective neurotomy. Several RCT placebo-controlled studies have demonstrated improvement in spasticity, in pain and in active ankle dorsiflexion after BTX injections. Unfortunately, BTX is an expensive treatment and its effects last about three months. Selective neurotomy consists in a partial section of the motor nerve innervating spastic muscles responsible for the SEF, leading to a permanent treatment of the SEF. Until now, neurotomy has only been assessed by observational case-report studies and has never been submitted to a RCT. The aim of our study is to evaluate the benefits of selective tibial neurotomy in case of SEF according to the 3 domains of the ICF, by comparing it with BTX injections, among a prospective, randomized, controlled single blind study: it would allow to promote a permanent and cost-effective treatment in case of SEF.
Study Details
Timeline
Interventions
Selective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles.
Botulinum toxin type A