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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001203-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox Injection | Experimental | Patients treated by botulinum toxin. |
|
| Saline Solution | Placebo Comparator | Patients treated with saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Drug | Experimental arm group:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The maximal strength measure | The maximal strength developed by injected muscles during gait. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Roche, MD | Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de médecine physique et réadaptation CHU de Brest | Brest | Brittany Region | 29290 | France | ||
| Nicolas Roche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30068305 | Derived | Supiot A, Geiger M, Bensmail D, Aegerter P, Pradon D, Roche N. Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX). BMC Neurol. 2018 Aug 2;18(1):104. doi: 10.1186/s12883-018-1110-8. |
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|
| injection of NaCl 0.9% | Drug | Placebo comparator group: injection of NaCl 0.9%:
|
|
| 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. | 1.5 hours |
| Garches |
| Hauts-de-Seine |
| 92380 |
| France |
| Centre de rééducation de l'ADAPT Montargis | Amilly | Loiret | 45420 | France |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| 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 |
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