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

Sponsors and Collaborators:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain Fonds National de la Recherche Scientifique
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00825097

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 III

MedlinePlus related topics: Botox Foot Health

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

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 ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Neurotomy Group: Experimental 10 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.
BTX Group: Active Comparator 10 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

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

Contacts

Contact: Thierry Deltombe, Professor

thierry.deltombe@uclouvain.be

Locations

Belgium
Université Catholique de Louvain - Cliniques universitaires Saint-Luc	Recruiting
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:

Jørgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32.

Verdié C, Daviet JC, Borie MJ, Popielarz S, Munoz M, Salle JY, Rebeyrotte I, Dudognon P. [Epidemiology of pes varus and/or equinus one year after a first cerebral hemisphere stroke: apropos of a cohort of 86 patients] Ann Readapt Med Phys. 2004 Mar;47(2):81-6. French.

Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34.

Burbaud P, Wiart L, Dubos JL, Gaujard E, Debelleix X, Joseph PA, Mazaux JM, Bioulac B, Barat M, Lagueny A. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):265-9.

Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovský P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon E. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300.

Mancini F, Sandrini G, Moglia A, Nappi G, Pacchetti C. A randomised, double-blind, dose-ranging study to evaluate efficacy and safety of three doses of botulinum toxin type A (Botox) for the treatment of spastic foot. Neurol Sci. 2005 Apr;26(1):26-31.

Decq P, Filipetti P, Cubillos A, Slavov V, Lefaucheur JP, Nguyen JP. Soleus neurotomy for treatment of the spastic equinus foot. Groupe d'Evaluation et de Traitement de la Spasticité et de la Dystonie. Neurosurgery. 2000 Nov;47(5):1154-60; discussion 1160-1.

Buffenoir K, Roujeau T, Lapierre F, Menei P, Menegalli-Boggelli D, Mertens P, Decq P. Spastic equinus foot: multicenter study of the long-term results of tibial neurotomy. Neurosurgery. 2004 Nov;55(5):1130-7.

Deltombe T, Detrembleur C, Hanson P, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot: a 2-year follow-up of three cases. Am J Phys Med Rehabil. 2006 Jan;85(1):82-8.

Stucki G. International Classification of Functioning, Disability, and Health (ICF): a promising framework and classification for rehabilitation medicine. Am J Phys Med Rehabil. 2005 Oct;84(10):733-40. No abstract available.

Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61.

Deltombe T, De Wispelaere JF, Gustin T, Jamart J, Hanson P. Selective blocks of the motor nerve branches to the soleus and tibialis posterior muscles in the management of the spastic equinovarus foot. Arch Phys Med Rehabil. 2004 Jan;85(1):54-8.

Detrembleur C, Lejeune TM, Plaghki L. [Objective measures of muscle stiffness in the ankle. Evaluation of the effect of intrathecal injection of baclofen in spastic patients] Neurochirurgie. 1998 Sep;44(3):197-200. French.

Caty GD, Arnould C, Stoquart GG, Thonnard JL, Lejeune TM. ABILOCO: a Rasch-built 13-item questionnaire to assess locomotion ability in stroke patients. Arch Phys Med Rehabil. 2008 Feb;89(2):284-90.

Responsible Party:	Cliniques universitaires Saint-Luc and Mont-Godinne ( Université Catholique de Louvain )
Study ID Numbers:	READ-Bollens-01
Study First Received:	November 14, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00825097 History of Changes
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

Study placed in the following topic categories:

Cerebral Infarction
Talipes Equinovarus
Stroke
Vascular Diseases
Clubfoot
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Muscle Spasticity

Botulinum Toxins
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Equinus Deformity
Peripheral Nervous System Agents
Botulinum Toxin Type A
Congenital Abnormalities
Foot Deformities

Additional relevant MeSH terms:

Foot Deformities, Acquired
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Neuromuscular Agents
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Musculoskeletal Diseases
Muscle Hypertonia
Therapeutic Uses
Cardiovascular Diseases
Botulinum Toxin Type A
Neuromuscular Manifestations
Nervous System Diseases

Stroke
Vascular Diseases
Central Nervous System Diseases
Clubfoot
Pharmacologic Actions
Muscle Spasticity
Muscular Diseases
Botulinum Toxins
Neurologic Manifestations
Equinus Deformity
Peripheral Nervous System Agents
Central Nervous System Agents
Foot Deformities
Foot Deformities, Congenital

ClinicalTrials.gov processed this record on May 07, 2009