Efficacy Study of Selective Tibial Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patients (Neurotomy)
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|ClinicalTrials.gov Identifier: NCT00825097|
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : December 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Spastic Equinovarus Foot Stroke||Procedure: Selective tibial neurotomy Drug: Botulinum toxin injection||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Neurotomy Group
8 patients undergoing a selective tibial neurotomy under general anesthesia
Procedure: Selective tibial neurotomy
Selective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles.
Active Comparator: BTX Group
8 patients undergoing a botulinum toxin injection in the calf muscles under EMG-control
Drug: Botulinum toxin injection
Botulinum toxin type A
- Impairments:SIAS,Ashworth and Tardieu scales and MRC scale. Spasticity and gait disorders:muscle stiffness measurement (15) and instrumented gait analysis (11). Disability: ABILOCO scale (16). Participation (quality of life) [ Time Frame: Before treatment (T0); 2 months (T1) and six months (T2) after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825097
|Université Catholique de Louvain - Cliniques universitaires Saint-Luc|
|Brussel, Belgium, 1200|
|Principal Investigator:||Benjamin Bollens, Doctor||Université Catholique de Louvain|