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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

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

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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

Conditions

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Stroke Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rectus femoris tenotomy

Surgical release of the proximal tendon of the rectus femoris

Group Type EXPERIMENTAL

Tenotomy of the proximal rectus femoris tendon

Intervention Type PROCEDURE

Surgical release of the proximal tendon of the rectus femoris

Botulinum toxin in the rectus femoris muscle

Botulinum toxin (200U Botox) injection in the rectus femoris muscle

Group Type ACTIVE_COMPARATOR

Botulinum Toxin injection in the rectus femoris muscle

Intervention Type DRUG

Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution

Interventions

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Tenotomy of the proximal rectus femoris tendon

Surgical release of the proximal tendon of the rectus femoris

Intervention Type PROCEDURE

Botulinum Toxin injection in the rectus femoris muscle

Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution

Intervention Type DRUG

Other Intervention Names

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Rectus femoris tenotomy Rectus femoris botulinum toxin A injections

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