Psychometric Properties Mobility Measures MS

NCT02339688 | Completed

• 1 other identifier: ML10457- S56574
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (9)

• Timed 25-Foot Walk test (T25FW)

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

• Timed up and go (TUG), TUGcognitive

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

• Two minute walk test (2MWT)

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

• Four Square Step Test (FSST)

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

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

  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)

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

• Rivermead Mobility Index (RMI)

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

• Multiple Sclerosis Walking Scale-12 (MSWS-12)

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

• Performance Scale mobility (PS-mob)

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

Secondary Outcomes (6)

• Timed Up and Go, manual

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

• Berg Balance Scale (BBS)

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

• Dynamic Gait index (DGI)

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

• Activities-specific Balance Confidence Scale (ABC)

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

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

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

Study Arms (1)

convential MS rehabilitation

OTHER

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

Other: conventional MS rehabilitation

Interventions

conventional MS rehabilitation OTHER

assessment pre and post conventional MS rehabilitation

convential MS rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Ilse Baert

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 15, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

BE (1)