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

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

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Spasticity
• Intervention / Treatment: Procedure: Tenotomy of the proximal rectus femoris tendon; Drug: Botulinum Toxin injection in the rectus femoris muscle

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Yvoir, Belgium, 5530
    • Recruiting
    • University Hospital of Mont-Godinne
    • Contact: Thierry Deltombe, M.D.; Phone Number: + 32 81 42 37 72; Email: thierry.deltombe@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Rectus femoris botulinum toxin A injections

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of Mont-Godinne
• Investigators: Principal Investigator: Thierry Deltombe, M.D., University Hospital of Mont-Godinne, Université Catholique de Louvain

Publications and helpful links

General Publications

• Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
• Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
• Namdari S, Pill SG, Makani A, Keenan MA. Rectus femoris to gracilis muscle transfer with fractional lengthening of the vastus muscles: a treatment for adults with stiff knee gait. Phys Ther. 2010 Feb;90(2):261-8. doi: 10.2522/ptj.20090151. Epub 2009 Dec 18.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: April 12, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 12, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Stroke; Botulinum toxin; Muscle spasticity; Stiff knee gait; Tenotomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A
• Other Study ID Numbers: MG-SKG-57/2013