Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Hasselt University
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Coin rotation task (CRT)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Investigators
Peter Feys
prof. dr.
Hasselt University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Coin rotation task (CRT)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale muscle weakness
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale sensory
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale fatigability
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Manual Ability Measurement (MAM-36)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Performance Scale hand function (PS hand)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Nine Hole Peg Test (NHPT)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Spasticity 0-10 numeric rating scale (NRS/VAS)
Time Frame: day 1, end of study
Visual Analogue Scale coordination
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Upper Extremity Motor Activity Log (EU-MAL)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Pinch strength
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
Box and Block Test (BBT)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
ABILHAND scale
Time Frame: day 1, end of study
a measure of manual ability for adults with upper limb impairment
Secondary Outcomes
- International Physical Activity Questionnaire (IPAQ)(day 1 and at the end of the rehabilitation, an expected average of three months)
- 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)
- 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)
- Trunk Impairment Scale modified Norwegian version (TIS-modNV)(day 1 and at the end of the rehabilitation, an expected average of three months)