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

Hospices Civils de Lyon23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical evaluation of the passive range of motion of the lower limbs

Secondary Outcomes

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