Psychometric Properties Mobility Measures MS (MCS-III-MOB)

June 13, 2016 updated by: Peter Feys, Hasselt University

Psychometric Properties of Mobility, Beyond Walking Speed, in Multiple Sclerosis: a Multi-center Study.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diepenbeek, Belgium, 3590
        • Hasselt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: convential MS rehabilitation
Investigation of the quality (psychometric properties) and clinical utility of several measures of mobility
Other: conventional MS rehabilitation
assessment pre and post conventional MS rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Timed 25-Foot Walk test (T25FW)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Timed up and go (TUG), TUGcognitive
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Two minute walk test (2MWT)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Four Square Step Test (FSST)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
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
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)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Rivermead Mobility Index (RMI)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Performance Scale mobility (PS-mob)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months

Secondary Outcome Measures

Outcome Measure
Time Frame
International Physical Activity Questionnaire (IPAQ)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Timed Up and Go, manual
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Berg Balance Scale (BBS)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Dynamic Gait index (DGI)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
Activities-specific Balance Confidence Scale (ABC)
Time Frame: day 1 and at the end of the rehabilitation, an expected average of three months
day 1 and at the end of the rehabilitation, an expected average of three months
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
day 1 and at the end of the rehabilitation, an expected average of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Charles University, Czech Republic
Queen's University
Haukeland University Hospital
Sheba Medical Center
Fondazione Don Carlo Gnocchi Onlus
St. Louis University
Italian Multiple Sclerosis Foundation
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek
Danish MS Hospitals, Haslev and Ry
MS Rehabilitation Center Borne Sulinowo
Eugenia Epalza Rehabilitation Center, Bilbao, Spain
De Mick
Dept Neurological Rehabilitation Reha Zentrum Münster Gröben
Masku Neurological Rehabilitation Center
Quellenhof
MS-Senteret Hakadal
Clinical center Belgrado
Cleveland Mellen MS Center
University of Colorado - Anschutz Medical Campus
Shepherd Center Atlanta

Investigators

  • Study Chair: Ilse Baert, Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML10457- S56574

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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