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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265238
• Other study ID #: MG-SEF-ICF-1
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: December 31, 2014
• Start date: December 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Muscle Spasticity
• Spastic Foot
• Spasticity
• Stroke

Locations

Country	Name	City	State
Belgium	University Hospital of Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

Bouffioulx E, Arnould C, Thonnard JL. SATIS-Stroke: A satisfaction measure of activities and participation in the actual environment experienced by patients with chronic stroke. J Rehabil Med. 2008 Nov;40(10):836-43. doi: 10.2340/16501977-0272. — View Citation

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. — View Citation

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. — View Citation

Deltombe T, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot in hemiplegic patients: a 2-year longitudinal follow-up of 30 cases. Arch Phys Med Rehabil. 2010 Jul;91(7):1025-30. doi: 10.1016/j.apmr.2010.04.010. — View Citation

Jørgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. — View Citation

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. — View Citation

Verdié C, Daviet JC, Borie MJ, Popielarz S, Munoz M, Salle JY, Rebeyrotte I, Dudognon P. [Epidemiology of pes varus and/or equinus one year after a first cerebral hemisphere stroke: apropos of a cohort of 86 patients]. Ann Readapt Med Phys. 2004 Mar;47(2):81-6. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke	Scale measuring disability, incapacity and participation	Before treatment (T0)	No
Primary	Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke	Scales measuring disability, incapacity and participation	2 months after surgery (T1)	No
Primary	Stroke impairment assessment scale, Ashworth scale, MRC scale, gait speed, Abiloco, SF36 and SATIS-stroke	Scale measuring disability, incapacity and participation	1 year after surgery (T2)	No