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Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke

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ClinicalTrials.gov Identifier: NCT02114736
Recruitment Status : Unknown
Verified April 2014 by Deltombe Thierry, University Hospital of Mont-Godinne.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Deltombe Thierry, University Hospital of Mont-Godinne

Brief Summary:

Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.

The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation


Condition or disease Intervention/treatment Phase
Stroke Spasticity Procedure: Tenotomy of the proximal rectus femoris tendon Drug: Botulinum Toxin injection in the rectus femoris muscle Phase 4

Detailed Description:

INTRODUCTION

Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.

The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .

OBJECTIVE

To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health

METHODS

The investigators will recruited 20 chronic stroke patients presenting with stiff knee gait. The patients will be randomly assigned to a surgical group treated by rectus femoris tenotomy (10 patients) and to a medical group treated by rectus femoris botulinum toxin A injections.

Patients will be assessed before treatment, 2 months and 6 months after treatment by an assessor blinded therapist among the 3 domains of the International Classification of Functioning Disability and Health

PERSPECTIVE

The investigator hope to demonstrate the effectiveness of the rectus femoris tenotomy as a treatment of stiff knee gait after stroke


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Rectus femoris tenotomy
Surgical release of the proximal tendon of the rectus femoris
Procedure: Tenotomy of the proximal rectus femoris tendon
Surgical release of the proximal tendon of the rectus femoris
Other Name: Rectus femoris tenotomy

Active Comparator: Botulinum toxin in the rectus femoris muscle
Botulinum toxin (200U Botox) injection in the rectus femoris muscle
Drug: Botulinum Toxin injection in the rectus femoris muscle
Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution
Other Name: Rectus femoris botulinum toxin A injections




Primary Outcome Measures :
  1. Ashworth scale at the rectus femoris [ Time Frame: 6 months ]
    Spasticity assessment scale


Secondary Outcome Measures :
  1. Stroke impairment assessment set (SIAS [ Time Frame: 6 months ]
    Body function and structure scale for stroke patients

  2. Tardieu scale [ Time Frame: 6 months ]
    Spasiticty assessment scale

  3. MRC (Medical research Council) scale [ Time Frame: 6 months ]
    Muscle strength scale

  4. Isometric muscle strenght assessment [ Time Frame: 6 months ]
    Objective muscle strenght with isometric dynamometer

  5. 10 meter walking test [ Time Frame: 6 months ]
    Gait speed assessment scale

  6. Instrumented gait analysis [ Time Frame: 6 months ]
    Kinetic and kinematic gait assessment in gait laboratory

  7. ABILOCO scale [ Time Frame: 6 months ]
    Activity level scale for gait validated according to Rasch model

  8. EQ-5D-5L scale [ Time Frame: 6 months ]
    Health quality of life scale



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke lasting for more than 6 months
  • stiff knee gait
  • rectus femoris spasticity (> Ashworth 2)
  • transient improvement with previous botulinum toxine A injection in the rectus femoris
  • stiff knee gait improved after rectus femoris diagnostic motor nere block
  • able to walk on treadmill

Exclusion Criteria:

  • pregnant women
  • botulinum toxin A injections in the rectus femoris < 6 months
  • previous surgery for stiff knee gait

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114736


Locations
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Belgium
University Hospital of Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Thierry Deltombe, M.D.    + 32 81 42 37 72    thierry.deltombe@uclouvain.be   
Sponsors and Collaborators
University Hospital of Mont-Godinne
Investigators
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Principal Investigator: Thierry Deltombe, M.D. University Hospital of Mont-Godinne, Université Catholique de Louvain

Publications:
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Responsible Party: Deltombe Thierry, Professeur Clinique, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT02114736     History of Changes
Other Study ID Numbers: MG-SKG-57/2013
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Deltombe Thierry, University Hospital of Mont-Godinne:
Stroke
Muscle spasticity
Stiff knee gait
Botulinum toxin
Tenotomy

Additional relevant MeSH terms:
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Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents