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

NCT00825097 | Completed Phase 3 DMC

• 1 other identifier: READ-Bollens-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spastic Equinovarus Foot; Stroke

Keywords

Spastic equinovarus foot; Stroke; Tibial neurotomy; Botulinum toxin type A; Selective tibial neurotomy

Outcome Measures

Primary Outcomes (1)

• 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)

  Before treatment (T0); 2 months (T1) and six months (T2) after treatment

Study Arms (2)

Neurotomy Group

EXPERIMENTAL

8 patients undergoing a selective tibial neurotomy under general anesthesia

Procedure: Selective tibial neurotomy

BTX Group

ACTIVE COMPARATOR

8 patients undergoing a botulinum toxin injection in the calf muscles under EMG-control

Drug: Botulinum toxin injection

Interventions

Selective tibial neurotomy PROCEDURE

Selective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles.

Neurotomy Group

Botulinum toxin injection DRUG

Botulinum toxin type A

BTX Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• patients unable to walk without orthosis on a treadmill

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (1)

Université Catholique de Louvain - Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (14)

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  PMID: 7811170 BACKGROUND

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  PMID: 15013602 BACKGROUND

• 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. doi: 10.1016/s1350-4533(01)00061-3.

  PMID: 11551819 BACKGROUND

• 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. doi: 10.1136/jnnp.61.3.265.

  PMID: 8795597 BACKGROUND

• Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovsky 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. doi: 10.1159/000069495.

  PMID: 12686794 BACKGROUND

• 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. doi: 10.1007/s10072-005-0378-9.

  PMID: 15877184 BACKGROUND

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  PMID: 11063109 BACKGROUND

• 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. doi: 10.1227/01.neu.0000140840.59586.cf.

  PMID: 15509319 BACKGROUND

• 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. doi: 10.1097/01.phm.0000193506.70371.cf.

  PMID: 16357553 BACKGROUND

• 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. doi: 10.1097/01.phm.0000179521.70639.83. No abstract available.

  PMID: 16205428 BACKGROUND

• 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. doi: 10.1016/j.apmr.2007.08.131.

  PMID: 18164331 BACKGROUND

• 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. doi: 10.1016/s0003-9993(03)00405-2.

  PMID: 14970968 BACKGROUND

• 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.

  PMID: 9827436 BACKGROUND

• 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. doi: 10.1016/j.apmr.2007.08.155.

  PMID: 18226652 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Benjamin Bollens, Doctor

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: January 19, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

BE (1)