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CompletedNCT02339688MCS-III-MOBUpdated Jun 14, 2016

Psychometric Properties Mobility Measures MS

An interventional study of conventional MS rehabilitation in Multiple Sclerosis, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-14.

Sponsored by Hasselt University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
254
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 254 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
254 participants (actual)

Study arms

  • Other
    convential MS rehabilitation

    Investigation of the quality (psychometric properties) and clinical utility of several measures of mobility

    Other: conventional MS rehabilitation

Interventions

  • Otherconventional MS rehabilitation

    assessment pre and post conventional MS rehabilitation

06

What researchers measure

Primary outcomes

  1. Timed 25-Foot Walk test (T25FW)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Timed up and go (TUG), TUGcognitive

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. Two minute walk test (2MWT)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  4. Four Square Step Test (FSST)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  5. 5 repetition sit-to-stand test (5STS-test)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  6. Modified 5 repetition sit-to-stand test (mod 5STS-test)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  7. Rivermead Mobility Index (RMI)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  8. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  9. Performance Scale mobility (PS-mob)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

Secondary outcomes

  1. Timed Up and Go, manual

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Berg Balance Scale (BBS)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. Dynamic Gait index (DGI)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  4. Activities-specific Balance Confidence Scale (ABC)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  5. Trunk Impairment Scale, modified Norwegian version (TIS-modNV)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  6. International Physical Activity Questionnaire (IPAQ)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

07

Study locations

1 site
  • Hasselt University
    Diepenbeek, 3590, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02339688
Lead sponsor
Hasselt University
Collaborators
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
Responsible party
Peter Feys (prof. dr., Hasselt University) — Principal investigator
First posted
Jan 15, 2015
Start date
Oct 2014
Primary completion
Dec 2015
Completion
Jun 2016
Last update
Jun 14, 2016

Study contacts

Peter Feys, prof. dr.
principal investigator · Hasselt University
Ilse Baert
study chair · Hasselt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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