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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

NCT01821573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-05-30

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicolas Roche, MD · Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-09-05
Completion
2019-05-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821573 on ClinicalTrials.gov