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

NCT01265238 | Completed

• 1 other identifier: MG-SEF-ICF-1
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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)

Conditions

Spasticity; Spastic Foot; Stroke

Keywords

Spastic equinovarus foot; Stroke; Neurotomy; Tendon surgery

Outcome Measures

Primary Outcomes (3)

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

  Scale measuring disability, incapacity and participation

  Before treatment (T0)

• 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)

• 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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• pregnant women
• botulinum toxin injection in the last 4 months
• previous surgery for SEF

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

University Hospital of Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (7)

• Jorgensen 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. doi: 10.1016/s0003-9993(95)80038-7.

  PMID: 7811170 BACKGROUND

• Verdie 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. doi: 10.1016/j.annrmp.2003.10.005. French.

  PMID: 15013602 BACKGROUND

• 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.

  PMID: 20599040 BACKGROUND

• 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. doi: 10.1016/s0003-9993(03)00405-2.

  PMID: 14970968 BACKGROUND

• 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.

  PMID: 18226652 BACKGROUND

• 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.

  PMID: 19242621 BACKGROUND

• 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. doi: 10.1097/01.phm.0000179521.70639.83. No abstract available.

  PMID: 16205428 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thierry M Deltombe, M.D.

  University Hospital of Mont-Godinne, Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur Clinique

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2014
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

BE (1)