Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
254 participants
INTERVENTIONAL
2014-10-31
2016-06-30
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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convential MS rehabilitation
Investigation of the quality (psychometric properties) and clinical utility of several measures of mobility
conventional MS rehabilitation
assessment pre and post conventional MS rehabilitation
Interventions
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conventional MS rehabilitation
assessment pre and post conventional MS rehabilitation
Eligibility Criteria
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Inclusion Criteria
* 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 neurological impairments with permanent damage (stroke, Parkinson, …)
* MS-like syndromes such as neuromyelitis optica
* not able to understand and execute simple instructions
18 Years
ALL
No
Sponsors
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Dept Neurological Rehabilitation Reha Zentrum Münster Gröben
UNKNOWN
National MS Center Melsbroek
OTHER
Revalidatie & MS Centrum Overpelt
OTHER
De Mick
UNKNOWN
Charles University, Czech Republic
OTHER
Danish MS Hospitals, Haslev and Ry
OTHER
Masku Neurological Rehabilitation Center
UNKNOWN
Quellenhof
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus
OTHER
Italian Multiple Sclerosis Foundation
OTHER
Sheba Medical Center
OTHER_GOV
MS-Senteret Hakadal
UNKNOWN
Haukeland University Hospital
OTHER
MS Rehabilitation Center Borne Sulinowo
UNKNOWN
Clinical center Belgrado
UNKNOWN
Eugenia Epalza Rehabilitation Center, Bilbao, Spain
OTHER
Cleveland Mellen MS Center
UNKNOWN
University of Colorado, Denver
OTHER
Queen's University
OTHER
Shepherd Center Atlanta
UNKNOWN
St. Louis University
OTHER
Hasselt University
OTHER
Responsible Party
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Peter Feys
prof. dr.
Principal Investigators
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Peter Feys, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Ilse Baert
Role: STUDY_CHAIR
Hasselt University
Locations
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Hasselt University
Diepenbeek, , Belgium
Countries
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Other Identifiers
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ML10457- S56574
Identifier Type: -
Identifier Source: org_study_id
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