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

• Status: Completed
• Trial end date: 2019-05-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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