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NCT Number: NCT01265238

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

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)

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke

    Time frame: 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

    Time frame: 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

    Time frame: 1 year after surgery (T2)

    Scale measuring disability, incapacity and participation

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Registry information

Official study title

Study of the Efficacy and Safety of the Neuro-orthopaedic Surgery in the Treatment of the Spastic Equinovarus Foot With ICF Assessment

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Dec 23, 2010
Registry last updated
Jan 1, 2015

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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