Clinical trial NCT01821573: 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
Official title: Double Blind Randomized Controlled Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength of These Muscles During Locomotion in Chronic Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO
Keywords: botulinum toxin injection,3D motion analysis, muscular lengthening,muscle strength
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measure of the maximal length of the muscles treated by Botulinum
timeFrame: 1.5 hours
Secondary outcomes:
measure: The maximal strength measure
timeFrame: 1.5 hours
measure: Inter-segmental coordination measure
timeFrame: 1.5 hours
measure: Measure of joint torque at knee and ankle level.
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Brest
country: France
facility: Service de médecine physique et réadaptation CHU de Brest
state: Bretagne
city: Garches
country: France
facility: Nicolas Roche
state: Hauts-de-Seine
city: Amilly
country: France
facility: Centre de rééducation de l'ADAPT Montargis
state: Loiret
Study officials:
affiliation: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
name: Nicolas Roche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.