Dettagli per singolo studio

DEC-NET Serial number GB516

Published online	21/11/2005 14.53.00
Last updated	21/11/2005 15.33.13


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	10/2002 100
Major Disease (ICD9 class)	OTHER SPECIFIED INFANTILE CEREBRAL PALSY
Experimental drug
BACLOFEN Treatment regimen (dosage and duration) Dose titrated to response. Given intrathecally via medtronic device
Gender	Both
Age (range)	5 - 18 years
Eligibility criteria
Inclusion criteria
Ambulant children with cerebral palsy
Exclusion criteria
Pure dystonia of other origin than cerebral palsy
Trial design/methodology
Phase	4
Kind of study	Efficacy Prophylaxis Safety
Design	Controlled Randomised Blinded Single blind
Purpose of study
Does Continuous infusion of intrathecal Baclofen in ambulant children improve mobillity, activities of daily living and quality of life.
Primary outcomes
This study will assess whether this technique is of significant benefit on tone, mobility, self help skills and quality of life.
Secondary outcomes
Cost benefit analysis of ITB vs Orthopaedic treatment and conservative management
Summary of study design, objectives, and ongoing research findings
The use of Baclofen in spasticity is well established, this efficacy audit aims to investigate the right indications of when to use it. Mild RCT with direct progression to treatment vs delay of 9 months before implant. The effect of this delay is monitored by means of quantifyable measures, GMFM, PEDI, QOLC etc. Initial results show ITB to be effective in both ambulant and non-ambulant spasticity. However no clear effect has been found on gait and function, so far.