Psychometric Properties Mobility Measures MS

Study Overview
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Brief Summary
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Current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, according to disability level. Therefore, several aspects will be inquired: Was there an effect of rehabilitation Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness) Does the measure assess what it claims to measure (validity) Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects) Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels. Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).

Official Title
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Psychometric Properties of Mobility, Beyond Walking Speed, in Multiple Sclerosis: a Multi-center Study.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: conventional MS rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MS according to McDonald criteria24, Expanded Disability Status Scale25 (EDSS) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician no relapse within the last month no changes in disease modifying treatment and no corticoid-therapy within the last month receive at least 10 sessions of physical therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months Exclusion Criteria: other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …) other neurological impairments with permanent damage (stroke, Parkinson, …) MS-like syndromes such as neuromyelitis optica not able to understand and execute simple instructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: convential MS rehabilitation<br>Investigation of the quality (psychometric properties) and clinical utility of several measures of mobility | Other: conventional MS rehabilitation<br>* assessment pre and post conventional MS rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25-Foot Walk test (T25FW) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Timed up and go (TUG), TUGcognitive |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Two minute walk test (2MWT) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Four Square Step Test (FSST) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| 5 repetition sit-to-stand test (5STS-test) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Modified 5 repetition sit-to-stand test (mod 5STS-test) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Rivermead Mobility Index (RMI) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Multiple Sclerosis Walking Scale-12 (MSWS-12) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Performance Scale mobility (PS-mob) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go, manual |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Berg Balance Scale (BBS) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Dynamic Gait index (DGI) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Activities-specific Balance Confidence Scale (ABC) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Trunk Impairment Scale, modified Norwegian version (TIS-modNV) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| International Physical Activity Questionnaire (IPAQ) |  | day 1 and at the end of the rehabilitation, an expected average of three months |