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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Hospital of Mont-Godinne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT01265238
First received: December 20, 2010
Last updated: December 22, 2010
Last verified: December 2010
  Purpose

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
Muscle Spasticity
Spastic Foot (Finding)
Stroke

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital of Mont-Godinne:

Primary Outcome Measures:
  • Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [ Time Frame: Before treatment (T0) ] [ Designated as safety issue: No ]
    Scale measuring disability, incapacity and participation

  • Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [ Time Frame: 2 months after surgery (T1) ] [ Designated as safety issue: No ]
    Scales measuring disability, incapacity and participation

  • Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke [ Time Frame: 1 year after surgery (T2) ] [ Designated as safety issue: No ]
    Scale measuring disability, incapacity and participation


Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with central neurological disease (stroke, traumatic brain injury, spinal cord injury, multiple sclerosis) suffering from a spastic equinovarus foot referred to an interdisciplinary spasticity group in a University Hospital

Criteria

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
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: NCT01265238

Contacts
Contact: Thierry M Deltombe, M.D. +32 81 42 37 72 thierry.deltombe@uclouvain.be

Locations
Belgium
University Hospital of Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Thierry M Deltombe, M.D.    + 32 81 42 37 72    thierry.deltombe@uclouvain.be   
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
  More Information

Publications:

Responsible Party: Thierry Deltombe Professeur Clinique, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01265238     History of Changes
Other Study ID Numbers: MG-SEF-ICF-1
Study First Received: December 20, 2010
Last Updated: December 22, 2010
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital of Mont-Godinne:
Spastic equinovarus foot
Stroke
Neurotomy
Tendon surgery

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Muscle Spasticity
Stroke
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired
Muscular Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014