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

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 5, 2017

Study Completion Date

May 23, 2019

Conditions
COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO
Interventions
DRUG

botulinum toxin type A

"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)"

DRUG

injection of NaCl 0.9%

"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"

Trial Locations (3)

29290

Service de médecine physique et réadaptation CHU de Brest, Brest

45420

Centre de rééducation de l'ADAPT Montargis, Amilly

92380

Nicolas Roche, Garches

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

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 | Biotech Hunter | Biotech Hunter