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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke

Conditions
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Stroke, Spasticity

Intervention / Treatment
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* Procedure: Tenotomy of the proximal rectus femoris tendon
* Drug: Botulinum Toxin injection in the rectus femoris muscle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectus femoris tenotomy<br>Surgical release of the proximal tendon of the rectus femoris | Procedure: Tenotomy of the proximal rectus femoris tendon<br>* Surgical release of the proximal tendon of the rectus femoris<br>* Other names: Rectus femoris tenotomy;|
| Active Comparator: Botulinum toxin in the rectus femoris muscle<br>Botulinum toxin (200U Botox) injection in the rectus femoris muscle | Drug: Botulinum Toxin injection in the rectus femoris muscle<br>* Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution<br>* Other names: Rectus femoris botulinum toxin A injections;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ashworth scale at the rectus femoris | Spasticity assessment scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke impairment assessment set (SIAS | Body function and structure scale for stroke patients | 6 months | 
| Tardieu scale | Spasiticty assessment scale | 6 months | 
| MRC (Medical research Council) scale | Muscle strength scale | 6 months | 
| Isometric muscle strenght assessment | Objective muscle strenght with isometric dynamometer | 6 months | 
| 10 meter walking test | Gait speed assessment scale | 6 months | 
| Instrumented gait analysis | Kinetic and kinematic gait assessment in gait laboratory | 6 months | 
| ABILOCO scale | Activity level scale for gait validated according to Rasch model | 6 months | 
| EQ-5D-5L scale | Health quality of life scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy