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

Recruiting

Phase 4 Results N/A

Trial Description

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

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

Interventions

  • Tenotomy of the proximal rectus femoris tendon Procedure
    Other Names: Rectus femoris tenotomy
    Intervention Desc: Surgical release of the proximal tendon of the rectus femoris
    ARM 1: Kind: Experimental
    Label: Rectus femoris tenotomy
    Description: Surgical release of the proximal tendon of the rectus femoris
  • Botulinum Toxin injection in the rectus femoris muscle Drug
    Other Names: Rectus femoris botulinum toxin A injections
    Intervention Desc: Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution
    ARM 1: Kind: Experimental
    Label: Botulinum toxin in the rectus femoris muscle
    Description: Botulinum toxin (200U Botox) injection in the rectus femoris muscle

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ashworth scale at the rectus femoris 6 months No
Secondary Stroke impairment assessment set (SIAS 6 months No
Secondary Tardieu scale 6 months No
Secondary MRC (Medical research Council) scale 6 months No
Secondary Isometric muscle strenght assessment 6 months No
Secondary 10 meter walking test 6 months No
Secondary Instrumented gait analysis 6 months No
Secondary ABILOCO scale 6 months No
Secondary EQ-5D-5L scale 6 months No

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