Clinical trial NCT02114736: Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Official title: A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Spasticity
Keywords: Stroke
Muscle spasticity
Stiff knee gait
Botulinum toxin
Tenotomy
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ashworth scale at the rectus femoris
timeFrame: 6 months
Secondary outcomes:
measure: Stroke impairment assessment set (SIAS
timeFrame: 6 months
measure: Tardieu scale
timeFrame: 6 months
measure: MRC (Medical research Council) scale
timeFrame: 6 months
measure: Isometric muscle strenght assessment
timeFrame: 6 months
measure: 10 meter walking test
timeFrame: 6 months
measure: Instrumented gait analysis
timeFrame: 6 months
measure: ABILOCO scale
timeFrame: 6 months
measure: EQ-5D-5L scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: University Hospital of Mont-Godinne
Study officials:
affiliation: University Hospital of Mont-Godinne, Université Catholique de Louvain
name: Thierry Deltombe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.