Psychometric Properties Mobility Measures MS

NCT ID: NCT02339688

Last Updated: 2016-06-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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convential MS rehabilitation

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

Group Type OTHER

conventional MS rehabilitation

Intervention Type OTHER

assessment pre and post conventional MS rehabilitation

Interventions

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conventional MS rehabilitation

assessment pre and post conventional MS rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dept Neurological Rehabilitation Reha Zentrum Münster Gröben

UNKNOWN

Sponsor Role collaborator

National MS Center Melsbroek

OTHER

Sponsor Role collaborator

Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

De Mick

UNKNOWN

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Danish MS Hospitals, Haslev and Ry

OTHER

Sponsor Role collaborator

Masku Neurological Rehabilitation Center

UNKNOWN

Sponsor Role collaborator

Quellenhof

UNKNOWN

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role collaborator

Italian Multiple Sclerosis Foundation

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

MS-Senteret Hakadal

UNKNOWN

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

MS Rehabilitation Center Borne Sulinowo

UNKNOWN

Sponsor Role collaborator

Clinical center Belgrado

UNKNOWN

Sponsor Role collaborator

Eugenia Epalza Rehabilitation Center, Bilbao, Spain

OTHER

Sponsor Role collaborator

Cleveland Mellen MS Center

UNKNOWN

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role collaborator

Shepherd Center Atlanta

UNKNOWN

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Feys

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Belgium

Other Identifiers

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ML10457- S56574

Identifier Type: -

Identifier Source: org_study_id

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