Cerebral Palsy
Conditions
Keywords
cerebral palsy children, Botulinum toxin
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.
Interventions
DRUGBotulinum toxin
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation of the passive range of motion of the lower limbs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed