Dettagli per singolo studio

DEC-NET Serial number FR543

Published online	10/07/2006 17.18.00
Last updated	10/07/2006 16.41.17

Other protocol ID number	2004.351/6
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Infantile cerebral palsy
Experimental drug
Botulinum toxin Treatment regimen (dosage and duration)
Gender	Both
Age (range)	7-17 years
Eligibility criteria
Inclusion criteria
-Children with cerebral palsy perinatal origin:hemiplegic, diplegic or quadriplegic -Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis. -Cognitive level compatible with the verbal communication, the respect of the instructions and the comprehension of the gestures carried out. -Compliants with a caring in rehabilitation -stabilized state after a possible surgical orthopedic operation -Patients with functional status allowing the use of botulinum toxin on target muscles.
Exclusion criteria
-Patients in whom botulinum toxin is contra-indicated -Patients who received botulinum toxin within a 6 month period before the beginning of the study -Patients who undergone a surgical orthopedic operation less than 1 year
Trial design/methodology
Phase	2
Kind of study	Efficacy
Design
Purpose of study
To validate clinical assessment and gait analysis data of botulinum toxin efficacy on both muscles rectus femoris (RF) and semitendinosus (ST), in order to optimize the multisite indications of botulinum toxin injection.
Primary outcomes
The principal outcome is a composite outcome including of the clinical data and the data measured by AQM. The modification of the values of the following parameters between before treatment and 2 months after treatment: -spasticity retained for the muscles with botulinic toxin injections, associated -extension of the knee associated -angular velocities data, associated -kinetic data.
Secondary outcomes
-
Summary of study design, objectives, and ongoing research findings
It is a interventionnal, multicentric multicentric, IIb phase study. It represents an open label therapeutic trial. The patients are their own control. 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.