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ID
Source
Brief title
Health condition
Patients with central neurological suffering and generalized spasticity during walking.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Background: The effect of interthecal baclofen (ITB) therapy on spasticity in central neurological disease (MS, CP, SCI, stroke) has been proven. However, literature on the effect on walking performance is scarce although there are indications that ITB therapy has a positive effect on patients’ walking performance when spasticity in the legs is problematic. In clinical practice, clinicians are often reluctant to expose patients with walking function to ITB therapy because of the risk of losing walking function due to spasm reduction. So far, objective evaluation of the effect of ITB therapy on walking performance is insufficiently investigated. Therefore, we would like to investigate the effect of ITB therapy on walking performance in patients with central neurological diseases.
Objective: The aim of this study is to investigate effectiveness of ITB therapy on walking performance in patients with central neurological diseases and impaired walking due to spasticity. A secondary explorative aim is investigating the dose-response relationship between the baclofen dose and daily walking activity.
Study design: Prospective observational cohort study (No controls).
Study population: 12-15 patients with central neurological suffering (e.g. MS, CP, SCI, stroke); in chronic phase (>6 months) and generalized spasticity during walking; indication for ITB therapy with planned admittance to SMK; ≥16 years.Intervention: 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 placed, the permanent ITB pump (ITBint admission). And during two physical therapy sessions; at baseline (preITB) and at twelve months follow-up (ITBfollow-up).
Main study parameters/endpoints: Primary outcome is the covered distance (meters) during the 2 minute walking test (2MWT). Secondary outcomes are spatiotemporal gait parameters, 10mWT, TUG, MAS, GAS, and BRPE & VAS scores regarding pain sensation, ease of walking and the hindrance from spasm during the 2MWT. Primary outcome for the dose-response relationship is the 10mWT score. Secondary outcomes are the MAS, gait parameters and VAS score regarding ease of walking during the 10mWT.
Study objective
It is hypothesized that patients will improve their gait performance overtime and an exponential curve is expected between baclofen dose and daily walking activity.
Study design
This observational cohort study has four timepoints. preITB: The baseline measurement will take place one week before the ITB trial, during physical therapy. ITBext: the ITB trial measurement will take place around the 4th day after placement of the ITB trial pump, during physical therapy. ITBint: the ITB measurement (if permanent ITB pump is placed) will take place around the 4th day after placement of the permanent ITB pump, during physical therapy. ITBfollow-up: The follow-up measurement (if permanent ITB pump is placed) will take place approximately 12 months after placement of the permanent ITB pump. During inpatient rehabilitation the participant will be monitored (ITBext admission and ITBint admission). All timepoints are part of usual care.
Intervention
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 placed, the permanent ITB pump (ITBint admission). And during two physical therapy sessions; at baseline (preITB) and at twelve months follow-up (ITBfollow-up).
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9150 |
| Other | METC Arnhem Nijmegen : 2019-5483 |