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

This study has been completed.
Sponsor:
Collaborator:
Fonds National de la Recherche Scientifique
Information provided by (Responsible Party):
Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00825097
First received: November 14, 2008
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Spastic Equinovarus Foot
Stroke
Procedure: Selective tibial neurotomy
Drug: Botulinum toxin injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic stroke patients (more than 6 months after stroke)
  • SEF due to spasticity of the calf muscles
  • Positive effects of lidocaïne selective motor nerve block
  • No associated tendinosous retraction: ankle dorsiflexion ≥ 0°after block
  • Insufficient benefit of adaptated kinesitherapy
  • Gait ability allowing an instrumented gait analysis

Exclusion Criteria:

  • Pregnant women
  • BTX injection in the lower limb during the 6 months before inclusion
  • BTX injection in another limb during the 6 months before inclusion
  • patients unable to walk without orthosis on a treadmill
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825097

Locations
Belgium
Université Catholique de Louvain - Cliniques universitaires Saint-Luc
Brussel, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Fonds National de la Recherche Scientifique
Investigators
Principal Investigator: Benjamin Bollens, Doctor Université Catholique de Louvain
  More Information

Publications:

Responsible Party: Lejeune, Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00825097     History of Changes
Other Study ID Numbers: READ-Bollens-01
Study First Received: November 14, 2008
Last Updated: December 22, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Spastic equinovarus foot
Stroke
Tibial neurotomy
Botulinum toxin type A
Selective tibial neurotomy

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Congenital Abnormalities
Foot Deformities
Foot Deformities, Acquired
Foot Deformities, Congenital
Limb Deformities, Congenital
Lower Extremity Deformities, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014