Psychometric Properties Upper Limb Function Measures Multiple Sclerosis

Study Overview
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Brief Summary
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Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, 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 Outcome Measures for Upper Limb Function, 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 criteria a treatment goal to maintain or improve upper limb function no relapse within the last month no changes in disease modifying medication and no corticoid-therapy within the last month receive at least 10 sessions of physical or occupational 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: convential MS rehabilitation<br>Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function | 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 |
| --- | --- | --- |
| Pinch strength |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Nine Hole Peg Test (NHPT) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Box and Block Test (BBT) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Coin rotation task (CRT) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Spasticity 0-10 numeric rating scale (NRS/VAS) |  | day 1, end of study | 
| Visual Analogue Scale muscle weakness |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Visual Analogue Scale sensory |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Visual Analogue Scale coordination |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Visual Analogue Scale fatigability |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Manual Ability Measurement (MAM-36) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| ABILHAND scale | a measure of manual ability for adults with upper limb impairment | day 1, end of study | 
| Performance Scale hand function (PS hand) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Upper Extremity Motor Activity Log (EU-MAL) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength (JAMAR) |  | day 1 and at the end of the rehabilitation, an expected average of three months | 
| Fatigability: plate tapping test |  | 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 | 
| Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec) |  | 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 |