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

Civil Hospices of Lyon

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cerebral Palsy

Treatments

Drug: Botulinum toxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00133861

2004.351

Details and patient eligibility

About

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.

Enrollment

23 estimated patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

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