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

U

University Hospital of Mont-Godinne

Status and phase

Unknown
Phase 4

Conditions

Spasticity
Stroke

Treatments

Procedure: Tenotomy of the proximal rectus femoris tendon
Drug: Botulinum Toxin injection in the rectus femoris muscle

Study type

Interventional

Funder types

Other

Identifiers

NCT02114736
MG-SKG-57/2013

Details and patient eligibility

About

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

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Rectus femoris tenotomy
Experimental group
Description:
Surgical release of the proximal tendon of the rectus femoris
Treatment:
Procedure: Tenotomy of the proximal rectus femoris tendon
Botulinum toxin in the rectus femoris muscle
Active Comparator group
Description:
Botulinum toxin (200U Botox) injection in the rectus femoris muscle
Treatment:
Drug: Botulinum Toxin injection in the rectus femoris muscle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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