Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength During Locomotion in Chronic Hemiparetic Patients
- Conditions
- COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO
- Interventions
- Drug: injection of NaCl 0.9%
- Registration Number
- NCT01821573
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.
The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.
The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.
- Detailed Description
The aim of this study is to compare versus placebo the effects of BTX-A injection on :
* the maximal length of the muscles injected during gait
* the maximal lengthening velocity of the muscles injected during gait
* the maximal strength of muscles injected during gait
* the inter-limb coordination assessed by continuous relative phase
* the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase.
To that end each patient included in the study will be assessed before injection, one month after the BTX-A injection and 3 months after BTX-A injections.
All patients will underwent a clinical examination, a 3D gait analysis and a isokinetic dynamometer analysis.
The comparison of the results in the group treated by BTX-A will permit to show that one month after BTX-A injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly.
It will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases It will also permit to demonstrate that multisite BTX-A injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite BTX-A injections.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- men or women aged > 18 ans
- unilateral stroke more than 6 months
- ability to walk 10 meters without assistive device
- decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of Rectus femoris muscle
- plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae
- informed consent approved
- oral contraception
- Aphasia
- anteriority of lower limb surgery less than 6 months
- underlying disease
- pre-existing neuro-muscular disorders
- pregnancy
- absence of oral contraception
- last botulinum toxin injection < 3months
- hypersensitivity reactions
- co-administration of aminoglycosides
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Solution injection of NaCl 0.9% Patients treated with saline solution. Botox Injection botulinum toxin type A Patients treated by botulinum toxin.
- Primary Outcome Measures
Name Time Method Measure of the maximal length of the muscles treated by Botulinum 1.5 hours The maximal length of the muscles treated by Botulinum Toxin during locomotion quantified using 3D motion analysis and musculo-skeletal model.
This measure will be performed one month after Botulinum toxin injection.
- Secondary Outcome Measures
Name Time Method Inter-segmental coordination measure 1.5 hours The modification of inter-segmental coordination during locomotion induced by botulinum toxin and quantified by continuous relative phase injection
The maximal strength measure 1.5 hours The maximal strength developed by injected muscles during gait.
Measure of joint torque at knee and ankle level. 1.5 hours The modification of joint torque at knee and ankle level induced by botulinum toxin injection.
Trial Locations
- Locations (3)
Service de médecine physique et réadaptation CHU de Brest
🇫🇷Brest, Bretagne, France
Centre de rééducation de l'ADAPT Montargis
🇫🇷Amilly, Loiret, France
Nicolas Roche
🇫🇷Garches, Hauts-de-Seine, France