Patients with central neurological suffering and generalized spasticity during walking.
Conditions
Interventions
To objectively explore the effect of the ITB therapy patients will be asked to wear IMUs on both ankles during daytime of their inpatient admissions of the ITB trial pump (ITBext admission) and, if pl
at baseline (preITB) and at twelve months follow-up (ITBfollow-up).
Sponsors
Sint Maartenskliniek
Eligibility
Inclusion criteria
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
Exclusion criteria: Unable to grant permission for participation in the study (due to language issues or cognitive impairment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the effect of ITB therapy on walking performance the main parameter is the covered distance (meters) in the two minute walking test (2MWT). 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
| Measure | Time frame |
|---|---|
| Secondary study parameters for the effect of ITB therapy on walking performance; I) Spatiotemporal gait parameters measured by IMUs to identify an effect in gait pattern (walking velocity, stride length, number of steps, cadence, average stride length). II) 10mWT score, time (seconds) to cover 10 meters. During normal and dual-task condition. III) TUG score, time (seconds) to stand up, walk 3 meters, turn, go back and sit down. IV) Modified Ashworth scale (MAS) to assess spasticity. V) Goal attainment scale (GAS) to identify if goals set were reached. VI) Borg rating of perceived exertion (BRPE) scale (6-20 scale) to grade the experienced intensity/physical load during the 2MWT. VII) Visual Analoge Scale (VAS) regarding pain sensation, ease of walking and the hindrance from spasm experienced during the 2MWT. Secondary study parameters for the dose-response relationship between baclofen dose and daily walking activity: I) Dose-response relationship between baclofen dose and other spatiotemporal gait parameters (number of walking periods, number of steps, walking dura-tion, cadence, average step length). II) Dose-response relationship between baclofen dose and MAS. III) Dose-response relationship between baclofen dose and VAS score | — |
Contacts
Public ContactMaartje Hendriks
Sint Maartenskliniek
Outcome results
None listed