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

Phase 4

• Conditions: Stroke; Spasticity
• Interventions: Procedure: Tenotomy of the proximal rectus femoris tendon; Drug: Botulinum Toxin injection in the rectus femoris muscle

• Registration Number: NCT02114736
• Lead Sponsor: 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

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-12
• Last Update Submitted: 2014-04-12
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus femoris tenotomy	Tenotomy of the proximal rectus femoris tendon	Surgical release of the proximal tendon of the rectus femoris
Botulinum toxin in the rectus femoris muscle	Botulinum Toxin injection in the rectus femoris muscle	Botulinum toxin (200U Botox) injection in the rectus femoris muscle

Primary Outcome Measures

Name	Time	Method
Ashworth scale at the rectus femoris	6 months	Spasticity assessment scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Mont-Godinne; 🇧🇪 Yvoir, Belgium