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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectus femoris tenotomy | Experimental | Surgical release of the proximal tendon of the rectus femoris |
|
| Botulinum toxin in the rectus femoris muscle | Active Comparator | Botulinum toxin (200U Botox) injection in the rectus femoris muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenotomy of the proximal rectus femoris tendon | Procedure | Surgical release of the proximal tendon of the rectus femoris |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ashworth scale at the rectus femoris | Spasticity assessment scale | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke impairment assessment set (SIAS | Body function and structure scale for stroke patients | 6 months |
| Tardieu scale | Spasiticty assessment scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Deltombe, M.D. | University Hospital of Mont-Godinne, Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Mont-Godinne | Recruiting | Yvoir | 5530 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18164331 | Background | 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. | |
| 18635841 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Botulinum Toxin injection in the rectus femoris muscle | Drug | Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution |
|
|
| 6 months |
| MRC (Medical research Council) scale | Muscle strength scale | 6 months |
| Isometric muscle strenght assessment | Objective muscle strenght with isometric dynamometer | 6 months |
| 10 meter walking test | Gait speed assessment scale | 6 months |
| Instrumented gait analysis | Kinetic and kinematic gait assessment in gait laboratory | 6 months |
| ABILOCO scale | Activity level scale for gait validated according to Rasch model | 6 months |
| EQ-5D-5L scale | Health quality of life scale | 6 months |
| 20023004 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |