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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings