Neuro-orthopaedic Surgery in the Treatment of the Spastic Equinovarus Foot
|ClinicalTrials.gov Identifier: NCT01265238|
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : January 1, 2015
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|
|Spasticity Spastic Foot Stroke|
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.
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.
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).
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 Type :||Observational|
|Actual Enrollment :||22 participants|
|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 :||December 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||December 2014|
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265238
|University Hospital of Mont-Godinne|
|Yvoir, Belgium, 5530|
|Principal Investigator:||Thierry M Deltombe, M.D.||University Hospital of Mont-Godinne, Université Catholique de Louvain|