Psychometric Properties Upper Limb Function Measures Multiple Sclerosis

NCT02339675 | Completed

• 1 other identifier: ML10456-S56575
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, 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 (13)

• Pinch strength

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

• Nine Hole Peg Test (NHPT)

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

• Box and Block Test (BBT)

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

• Coin rotation task (CRT)

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

• Spasticity 0-10 numeric rating scale (NRS/VAS)

  day 1, end of study

• Visual Analogue Scale muscle weakness

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

• Visual Analogue Scale sensory

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

• Visual Analogue Scale coordination

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

• Visual Analogue Scale fatigability

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

• Manual Ability Measurement (MAM-36)

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

• ABILHAND scale

  a measure of manual ability for adults with upper limb impairment

  day 1, end of study

• Performance Scale hand function (PS hand)

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

• Upper Extremity Motor Activity Log (EU-MAL)

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

Secondary Outcomes (5)

• Hand grip strength (JAMAR)

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

• Fatigability: plate tapping test

  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

• Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)

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

• International Physical Activity Questionnaire (IPAQ)

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

Study Arms (1)

convential MS rehabilitation

OTHER

Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function

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 criteria
• a treatment goal to maintain or improve upper limb function
• no relapse within the last month
• no changes in disease modifying medication and no corticoid-therapy within the last month
• receive at least 10 sessions of physical or occupational 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
• Revalidatie & MS Centrum Overpelt: collaborator
• Charles University, Czech Republic: collaborator
• Danish MS Hospitals, Haslev and Ry: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Italian Multiple Sclerosis Foundation: collaborator
• centrisclerosimultipla: collaborator
• Sheba Medical Center: collaborator
• Haukeland University Hospital: collaborator
• MS Rehabilitation Center Borne Sulinowo: collaborator
• University of Ljubljana: collaborator
• Eugenia Epalza Rehabilitation Center, Bilbao, Spain: collaborator
• Day General Hospital.: collaborator
• Shepherd Center, Atlanta GA: collaborator
• Queen's University: collaborator
• St. Louis University: collaborator
• De Mick: collaborator
• MS center Hakadal AS: 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, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• 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: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

BE (1)