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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
conventional MS rehabilitation
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasselt University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

convential MS rehabilitation

Arm Description

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

Outcomes

Primary Outcome Measures

Pinch strength
Nine Hole Peg Test (NHPT)
Box and Block Test (BBT)
Coin rotation task (CRT)
Spasticity 0-10 numeric rating scale (NRS/VAS)
Visual Analogue Scale muscle weakness
Visual Analogue Scale sensory
Visual Analogue Scale coordination
Visual Analogue Scale fatigability
Manual Ability Measurement (MAM-36)
ABILHAND scale
a measure of manual ability for adults with upper limb impairment
Performance Scale hand function (PS hand)
Upper Extremity Motor Activity Log (EU-MAL)

Secondary Outcome Measures

Hand grip strength (JAMAR)
Fatigability: plate tapping test
Trunk Impairment Scale modified Norwegian version (TIS-modNV)
Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)
International Physical Activity Questionnaire (IPAQ)

Full Information

First Posted
December 16, 2014
Last Updated
May 20, 2020
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Charles University, Czech Republic, Danish MS Hospitals, Haslev and Ry, Fondazione Don Carlo Gnocchi Onlus, Italian Multiple Sclerosis Foundation, centrisclerosimultipla, Sheba Medical Center, Haukeland University Hospital, MS Rehabilitation Center Borne Sulinowo, University of Ljubljana, Eugenia Epalza Rehabilitation Center, Bilbao, Spain, Day General Hospital., Shepherd Center, Atlanta GA, Queen's University, St. Louis University, De Mick, MS center Hakadal AS
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1. Study Identification

Unique Protocol Identification Number
NCT02339675
Brief Title
Psychometric Properties Upper Limb Function Measures Multiple Sclerosis
Acronym
MCS-III-UL
Official Title
Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Charles University, Czech Republic, Danish MS Hospitals, Haslev and Ry, Fondazione Don Carlo Gnocchi Onlus, Italian Multiple Sclerosis Foundation, centrisclerosimultipla, Sheba Medical Center, Haukeland University Hospital, MS Rehabilitation Center Borne Sulinowo, University of Ljubljana, Eugenia Epalza Rehabilitation Center, Bilbao, Spain, Day General Hospital., Shepherd Center, Atlanta GA, Queen's University, St. Louis University, De Mick, MS center Hakadal AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
convential MS rehabilitation
Arm Type
Other
Arm Description
Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function
Intervention Type
Other
Intervention Name(s)
conventional MS rehabilitation
Intervention Description
assessment pre and post conventional MS rehabilitation
Primary Outcome Measure Information:
Title
Pinch strength
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Nine Hole Peg Test (NHPT)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Box and Block Test (BBT)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Coin rotation task (CRT)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Spasticity 0-10 numeric rating scale (NRS/VAS)
Time Frame
day 1, end of study
Title
Visual Analogue Scale muscle weakness
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Visual Analogue Scale sensory
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Visual Analogue Scale coordination
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Visual Analogue Scale fatigability
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Manual Ability Measurement (MAM-36)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
ABILHAND scale
Description
a measure of manual ability for adults with upper limb impairment
Time Frame
day 1, end of study
Title
Performance Scale hand function (PS hand)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Upper Extremity Motor Activity Log (EU-MAL)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Secondary Outcome Measure Information:
Title
Hand grip strength (JAMAR)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Fatigability: plate tapping test
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Trunk Impairment Scale modified Norwegian version (TIS-modNV)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months
Title
International Physical Activity Questionnaire (IPAQ)
Time Frame
day 1 and at the end of the rehabilitation, an expected average of three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilse Baert, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium

12. IPD Sharing Statement

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