Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
assessment pre and post conventional MS rehabilitation
Sponsors
Dept Neurological Rehabilitation Reha Zentrum Münster Gröben
National MS Center Melsbroek
Revalidatie & MS Centrum Overpelt
De Mick
Charles University, Czech Republic
Danish MS Hospitals, Haslev and Ry
Masku Neurological Rehabilitation Center
Quellenhof
Fondazione Don Carlo Gnocchi Onlus
Italian Multiple Sclerosis Foundation
Sheba Medical Center
MS-Senteret Hakadal
Haukeland University Hospital
MS Rehabilitation Center Borne Sulinowo
Clinical center Belgrado
Eugenia Epalza Rehabilitation Center, Bilbao, Spain
Cleveland Mellen MS Center
University of Colorado, Denver
Queen's University
Shepherd Center Atlanta
St. Louis University
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance Scale mobility (PS-mob) | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Timed Up and Go, manual | day 1 and at the end of the rehabilitation, an expected average of three months |
Countries
Belgium
Outcome results
None listed