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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Experimental arm group: * 150 Units in rectus femoris ( 3 ml and 3 points) * 70 units in medial gastrocnemius (1.4 ml and 1 point) * 70 units in lateral gastrocnemius ( 1.4 ml and 1 point) * 60 units in soleus ( 1.2 ml and 3 points)
Placebo comparator group: injection of NaCl 0.9%: * 3 ml of NaCl 0.9% in rectus femoris in 3 points * 1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point * 1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point * 1.2 ml of NaCl 0.9% in soleus in 3 points
Service de médecine physique et réadaptation CHU de Brest
Brest, Brittany Region, France
Nicolas Roche
Garches, Hauts-de-Seine, France
Centre de rééducation de l'ADAPT Montargis
Amilly, Loiret, France
Measure of the maximal length of the muscles treated by Botulinum
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.
Time frame: 1.5 hours
The maximal strength measure
The maximal strength developed by injected muscles during gait.
Time frame: 1.5 hours
Inter-segmental coordination measure
The modification of inter-segmental coordination during locomotion induced by botulinum toxin and quantified by continuous relative phase injection
Time frame: 1.5 hours
Measure of joint torque at knee and ankle level.
The modification of joint torque at knee and ankle level induced by botulinum toxin injection.
Time frame: 1.5 hours
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