Overview

Efficacy Study of Selective Tibial Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patients

Status:
Completed

Trial end date:
2011-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborator:

Fonds National de la Recherche Scientifique

Treatments:

abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA