Psychometric Properties Upper Limb Function Measures Multiple Sclerosis (MCS-III-UL)

Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: conventional MS rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Hasselt University

Participation Criteria

Eligibility Criteria

• 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 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

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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: convential MS rehabilitation; Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function	Other: conventional MS rehabilitation; assessment pre and post conventional MS rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Charles University, Czech Republic; Queen's University; Haukeland University Hospital; Sheba Medical Center; Fondazione Don Carlo Gnocchi Onlus; University of Ljubljana; St. Louis University; Shepherd Center, Atlanta GA; Italian Multiple Sclerosis Foundation; Revalidatie & MS Centrum Overpelt; Danish MS Hospitals, Haslev and Ry; centrisclerosimultipla; MS Rehabilitation Center Borne Sulinowo; Eugenia Epalza Rehabilitation Center, Bilbao, Spain; Day General Hospital.; De Mick; MS center Hakadal AS
• Investigators: Study Chair: Ilse Baert, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (ESTIMATE): January 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: ML10456-S56575