Clinical trial NCT02339688: Psychometric Properties Mobility Measures MS
Official title: Psychometric Properties of Mobility, Beyond Walking Speed, in Multiple Sclerosis: a Multi-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Dept Neurological Rehabilitation Reha Zentrum Münster Gröben
name: National MS Center Melsbroek
name: Revalidatie & MS Centrum Overpelt
name: De Mick
name: Charles University, Czech Republic
name: Danish MS Hospitals, Haslev and Ry
name: Masku Neurological Rehabilitation Center
name: Quellenhof
name: Fondazione Don Carlo Gnocchi Onlus
name: Italian Multiple Sclerosis Foundation
name: Sheba Medical Center
name: MS-Senteret Hakadal
name: Haukeland University Hospital
name: MS Rehabilitation Center Borne Sulinowo
name: Clinical center Belgrado
name: Eugenia Epalza Rehabilitation Center, Bilbao, Spain
name: Cleveland Mellen MS Center
name: University of Colorado, Denver
name: Queen's University
name: Shepherd Center Atlanta
name: St. Louis University
First posted: 2015-01-15
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).


Eligibility criteria: 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

Primary outcomes:
measure: Timed 25-Foot Walk test (T25FW)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Timed up and go (TUG), TUGcognitive
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Two minute walk test (2MWT)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Four Square Step Test (FSST)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: 5 repetition sit-to-stand test (5STS-test)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Modified 5 repetition sit-to-stand test (mod 5STS-test)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Rivermead Mobility Index (RMI)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Performance Scale mobility (PS-mob)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
Secondary outcomes:
measure: Timed Up and Go, manual
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Berg Balance Scale (BBS)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Dynamic Gait index (DGI)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Activities-specific Balance Confidence Scale (ABC)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Trunk Impairment Scale, modified Norwegian version (TIS-modNV)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Ilse Baert
role: STUDY_CHAIR
References: