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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02114736
• Other study ID #: MG-SKG-57/2013
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2014
• Last updated: April 12, 2014
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2014
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity
• Stroke

Intervention

Procedure:
• Tenotomy of the proximal rectus femoris tendon
Surgical release of the proximal tendon of the rectus femoris

Drug:
• Botulinum Toxin injection in the rectus femoris muscle
Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution

Locations

Country	Name	City	State
Belgium	University Hospital of Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ashworth scale at the rectus femoris	Spasticity assessment scale	6 months	No
Secondary	Stroke impairment assessment set (SIAS	Body function and structure scale for stroke patients	6 months	No
Secondary	Tardieu scale	Spasiticty assessment scale	6 months	No
Secondary	MRC (Medical research Council) scale	Muscle strength scale	6 months	No
Secondary	Isometric muscle strenght assessment	Objective muscle strenght with isometric dynamometer	6 months	No
Secondary	10 meter walking test	Gait speed assessment scale	6 months	No
Secondary	Instrumented gait analysis	Kinetic and kinematic gait assessment in gait laboratory	6 months	No
Secondary	ABILOCO scale	Activity level scale for gait validated according to Rasch model	6 months	No
Secondary	EQ-5D-5L scale	Health quality of life scale	6 months	No