Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles

Phase 2

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT00133861
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-30
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Patients between 7 to 17 years old
• Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis.
• Patients with functional status allowing the use of botulinum toxin on target muscles.

Exclusion Criteria

• Patients under 7 years old
• Patients up to 17 years old
• Patients in whom botulinum toxin is contra-indicated
• Patients who received botulinum toxin within a 6 month period before the beginning of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of the passive range of motion of the lower limbs

Secondary Outcome Measures

Name	Time	Method
Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index

Trial Locations

Locations (1)

Hôpital Edouard Herriot - Pavillon T bis; 🇫🇷 Lyon, France