Status:
COMPLETED
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
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Allergan
Conditions:
COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 injec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01821573
Start Date
July 1 2013
End Date
May 23 2019
Last Update
May 30 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de médecine physique et réadaptation CHU de Brest
Brest, Brittany Region, France, 29290
2
Nicolas Roche
Garches, Hauts-de-Seine, France, 92380
3
Centre de rééducation de l'ADAPT Montargis
Amilly, Loiret, France, 45420