Effect of intrathecal baclofen (ITB) therapy in ambulatory patients with generalized spasticity
Recruiting
- Conditions
- Patients with central neurological suffering and generalized spasticity during walking.
- Registration Number
- NL-OMON27247
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
I) Patients with neurological suffering (e.g. MS, CP, SCI, stroke). II) In chronic phase (>6 months). III) Generalized spasticity during walking (determined by instrumental gait analysis). IV) Indication for ITB therapy with planned admittance to SMK. V) =16 years. VI) The use of walking aids is permitted.
Exclusion Criteria
Unable to grant permission for participation in the study (due to language issues or cognitive impairment).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For the effect of ITB therapy on walking performance the main parameter is the covered distance (meters) in the two minute walking test (2MWT).<br>For the dose-response relationship between the baclofen dose and daily walking activity the main parameter is the dose-response relationship between the baclofen dose and the 10 meter walking test (10mWT) score.
- Secondary Outcome Measures
Name Time Method