Psychometric Properties Upper Limb Function Measures Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Other: conventional MS rehabilitation
- Registration Number
- NCT02339675
- Lead Sponsor
- Hasselt University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description convential MS rehabilitation conventional MS rehabilitation Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function
- Primary Outcome Measures
Name Time Method Coin rotation task (CRT) day 1 and at the end of the rehabilitation, an expected average of three months 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 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 Performance Scale hand function (PS hand) 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 Spasticity 0-10 numeric rating scale (NRS/VAS) day 1, end of study Visual Analogue Scale coordination 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 Pinch strength 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 ABILHAND scale day 1, end of study a measure of manual ability for adults with upper limb impairment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hasselt University
🇧🇪Diepenbeek, Belgium