muscle spasms spasticity
Conditions
Interventions
All patients will receive ITB test-infusion at different dosages during 5 days
at the neurology ward.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Spastic gait, not responsive on optimal oral spasmolytics -Age 18-75 yrs (female patients at fertile age need to guarantee adequate anti-conception) -Accept definite ITB pump implantation as a consequence of a positive test-phase -Able to understand the verbal written and instructions -Able to sign the informed consent
Exclusion criteria
Exclusion criteria: -Patients using thrombolytic therapy, which can not be stopped -Patients with low platelets (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decision whether a permanent ITB-pump will be implanted or not, based on the effect of the ITB test-infusion, and measured by the Patient*s Global Impression of Change-scale (PGIC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters: The outcome of eight different tests divided over three domains, which are performed at baseline and after each ITB bolus infusion: Strength (2 items) oManual Strength testing using the MRC-scale oDynamometry Spasticity (2 items) oModified Ashworth Scale (MAS) oHofmann-reflex Function (4 items) oTimed up and go test (TUG) oKnee- and ankle range of motion (ROM) oAmbulation Index (AI) oBarthell-index Other study parameters: Patient characteristics, SIP68-questionaire to assess the impact of the impairment. | — |
Countries
Netherlands
Outcome results
None listed