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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02114736
Enrollment
20
Registered
2014-04-15
Start date
2014-03-31
Completion date
2017-12-31
Last updated
2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity, Stroke

Keywords

Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy

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

Interventions

PROCEDURETenotomy of the proximal rectus femoris tendon

Surgical release of the proximal tendon of the rectus femoris

DRUGBotulinum Toxin injection in the rectus femoris muscle

Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution

Sponsors

University Hospital of Mont-Godinne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ashworth scale at the rectus femoris6 monthsSpasticity assessment scale

Secondary

MeasureTime frameDescription
Tardieu scale6 monthsSpasiticty assessment scale
MRC (Medical research Council) scale6 monthsMuscle strength scale
Isometric muscle strenght assessment6 monthsObjective muscle strenght with isometric dynamometer
Stroke impairment assessment set (SIAS6 monthsBody function and structure scale for stroke patients
Instrumented gait analysis6 monthsKinetic and kinematic gait assessment in gait laboratory
ABILOCO scale6 monthsActivity level scale for gait validated according to Rasch model
EQ-5D-5L scale6 monthsHealth quality of life scale
10 meter walking test6 monthsGait speed assessment scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026