Multiple Sclerosis
Conditions
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).
Interventions
assessment pre and post conventional MS rehabilitation
Sponsors
Revalidatie & MS Centrum Overpelt
Charles University, Czech Republic
Danish MS Hospitals, Haslev and Ry
Fondazione Don Carlo Gnocchi Onlus
Italian Multiple Sclerosis Foundation
centrisclerosimultipla
Sheba Medical Center
Haukeland University Hospital
MS Rehabilitation Center Borne Sulinowo
University of Ljubljana
Eugenia Epalza Rehabilitation Center, Bilbao, Spain
Day General Hospital.
Shepherd Center, Atlanta GA
Queen's University
St. Louis University
De Mick
MS center Hakadal AS
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Scale hand function (PS hand) | 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 | day 1, end of study | a measure of manual ability for adults with upper limb impairment |
| 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 | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Hand grip strength (JAMAR) | day 1 and at the end of the rehabilitation, an expected average of three months |
Countries
Belgium
Outcome results
None listed