Neuro-orthopaedic Surgery in the Treatment of the Spastic Equinovarus Foot

Sponsor
University Hospital of Mont-Godinne (Other)
Overall Status
Completed
CT.gov ID
NCT01265238
Collaborator
(none)
22
1
60
0.4

Study Details

Study Description

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, selective tibial neurotomy and tendon lengthening and/or transfer.

Until now, no study has been conducted to assess the result of neuro-orthopaedic surgery in the treatment of SEF.

The aim of this study is to evaluate the benefit of neuro-orthopaedic surgery (selective neurotomy and/or Achilles tendon lengthening and/or tibialis anterior transfer) in case of SEF according to the 3 domains of the International Classification of Functioning, Disability and Health (ICF)of the World Health organisation (WHO)

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    INTRODUCTION

    Stroke is the third cause of death and the leading cause of handicap among industrialized countries (1). Spasticity following stroke is responsible for spastic equinovarus foot (SEF) in 18% of cases (2). Spastic equinovarus foot is due to spasticity (muscle hypertonia) of the calf muscles (soleus, gastrocnemius and tibialis posterior), often complicated by contracture and by the weakness of peroneus longus and peroneus brevis muscles (3). Therefore, stroke patients walk slowly, and often require assistive device as orthosis or canes. This disability limits their social participation and their quality of life.

    Spastic equinovarus foot treatments include oral medications, physical therapy, orthosis, chemical denervations (botulinum toxin, alcohol or phenol injections), selective neurotomy and orthopedic surgery (3). Selective neurotomy is a neurosurgical procedure consisting in partially and selectively cutting motor branches innervating the spastic muscles providing a permanent treatment of the spasticity (3). Orthopaedic surgery consists in Achilles tendon lengthening and tibialis anterior transfer (3). The efficacy of mixed neur-orthopaedic surgery has never been prospectively assess according to the ICF classification.

    OBJECTIVES

    The aim of the present project is to study the effectiveness of neuro-orthopaedic surgery (neurotomy and tendon surgery) in the treatment of SEF.

    The functional assessment will explore the three ICF domains.

    METHODS

    The investigators will recruit 50 chronic spastic patients presenting with SEF. The surgical treatment will be decided according to the improvement obtained by an anaesthetic diagnostic tibial motor nerve branches block (5) followed by an interdisciplinary discussion.

    Patients will be assessed before treatment, 2 months, 1 year and 2 years after treatment among the 3 ICF domains. Impairments will be assessed by the Stoke Impairment Assessment Set (SIAS), the Ashworth and Tardieu scales (spasticity) and the MRC scale (muscle strength). Gait disorders will be evaluated by a video analysis. Disability will be evaluated by the ABILOCO scale (6) and the participation (quality of life) by the SATIS-Stroke questionnaire (7) and the SF-36 questionnaire.

    The patients selection, the lidocaine hyperselective diagnostic blocks, the selective neurotomy and the tendon surgery will be achieved by the medical doctors participants to the spasticity group. The functional assessment will be achieved by the physical therapists of the PMR department (blinded assessor).

    PERSPECTIVE

    The investigators hope to demonstrate the benefit of neuro-orthopaedic surgery in case of SEF according to the 3 domains of the ICF (8)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Study of the Efficacy and Safety of the Neuro-orthopaedic Surgery in the Treatment of the Spastic Equinovarus Foot With ICF Assessment
    Study Start Date :
    Dec 1, 2009
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [Before treatment (T0)]

      Scale measuring disability, incapacity and participation

    2. Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [2 months after surgery (T1)]

      Scales measuring disability, incapacity and participation

    3. Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [1 year after surgery (T2)]

      Scale measuring disability, incapacity and participation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • central neurological disease lasting from more than 6 months

    • spastic equinovarus foot due to spasticity and/or contracture

    • patient able to walk barefoot

    • insufficient benefit from physical therapy and/or orthosis

    Exclusion Criteria:
    • pregnant women

    • botulinum toxin injection in the last 4 months

    • previous surgery for SEF

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Mont-Godinne Yvoir Belgium 5530

    Sponsors and Collaborators

    • University Hospital of Mont-Godinne

    Investigators

    • Principal Investigator: Thierry M Deltombe, M.D., University Hospital of Mont-Godinne, Université Catholique de Louvain

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Deltombe Thierry, Professeur Clinique, University Hospital of Mont-Godinne
    ClinicalTrials.gov Identifier:
    NCT01265238
    Other Study ID Numbers:
    • MG-SEF-ICF-1
    First Posted:
    Dec 23, 2010
    Last Update Posted:
    Jan 1, 2015
    Last Verified:
    Dec 1, 2014
    Keywords provided by Deltombe Thierry, Professeur Clinique, University Hospital of Mont-Godinne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 1, 2015