Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

able to walk on treadmill
stiff knee gait improved after rectus femoris diagnostic motor nere block
stroke lasting for more than 6 months
...
able to walk on treadmill
stiff knee gait improved after rectus femoris diagnostic motor nere block
stroke lasting for more than 6 months
transient improvement with previous botulinum toxine A injection in the rectus femoris
stiff knee gait
rectus femoris spasticity (> Ashworth 2)

Exclusion Criterias

botulinum toxin A injections in the rectus femoris < 6 months
pregnant women
previous surgery for stiff knee gait
botulinum toxin A injections in the rectus femoris < 6 months
pregnant women
previous surgery for stiff knee gait

Summary

Conditions
  • Spasticity
  • Stroke
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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...

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

Inclusion Criterias

able to walk on treadmill
stiff knee gait improved after rectus femoris diagnostic motor nere block
stroke lasting for more than 6 months
...
able to walk on treadmill
stiff knee gait improved after rectus femoris diagnostic motor nere block
stroke lasting for more than 6 months
transient improvement with previous botulinum toxine A injection in the rectus femoris
stiff knee gait
rectus femoris spasticity (> Ashworth 2)

Exclusion Criterias

botulinum toxin A injections in the rectus femoris < 6 months
pregnant women
previous surgery for stiff knee gait
botulinum toxin A injections in the rectus femoris < 6 months
pregnant women
previous surgery for stiff knee gait

Locations

Yvoir, 5530
Yvoir, 5530

Tracking Information

NCT #
NCT02114736
Collaborators
Not Provided
Investigators
  • Principal Investigator: Thierry Deltombe, M.D. University Hospital of Mont-Godinne, Université Catholique de Louvain
  • Thierry Deltombe, M.D. University Hospital of Mont-Godinne, Université Catholique de Louvain