Psychometric Properties Mobility Measures MS

Multiple Sclerosis Clinical Trial

— MCS-III-MOB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339688
• Other study ID #: ML10457- S56574
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: June 13, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• conventional MS rehabilitation
assessment pre and post conventional MS rehabilitation

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek

Sponsors (22)

Lead Sponsor

Collaborator

Hasselt University

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed 25-Foot Walk test (T25FW)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Timed up and go (TUG), TUGcognitive		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Two minute walk test (2MWT)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Four Square Step Test (FSST)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	5 repetition sit-to-stand test (5STS-test)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Modified 5 repetition sit-to-stand test (mod 5STS-test)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Rivermead Mobility Index (RMI)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Multiple Sclerosis Walking Scale-12 (MSWS-12)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Primary	Performance Scale mobility (PS-mob)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	Timed Up and Go, manual		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	Berg Balance Scale (BBS)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	Dynamic Gait index (DGI)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	Activities-specific Balance Confidence Scale (ABC)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	Trunk Impairment Scale, modified Norwegian version (TIS-modNV)		day 1 and at the end of the rehabilitation, an expected average of three months	No
Secondary	International Physical Activity Questionnaire (IPAQ)		day 1 and at the end of the rehabilitation, an expected average of three months	No