Psychometric Properties Upper Limb Function Measures Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MCS-III-UL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339675
• Other study ID #: ML10456-S56575
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 (18)

Lead Sponsor

Collaborator

Hasselt University

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pinch strength		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Nine Hole Peg Test (NHPT)		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Box and Block Test (BBT)		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Coin rotation task (CRT)		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Spasticity 0-10 numeric rating scale (NRS/VAS)		day 1, end of study
Primary	Visual Analogue Scale muscle weakness		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Visual Analogue Scale sensory		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Visual Analogue Scale coordination		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Visual Analogue Scale fatigability		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Manual Ability Measurement (MAM-36)		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	ABILHAND scale	a measure of manual ability for adults with upper limb impairment	day 1, end of study
Primary	Performance Scale hand function (PS hand)		day 1 and at the end of the rehabilitation, an expected average of three months
Primary	Upper Extremity Motor Activity Log (EU-MAL)		day 1 and at the end of the rehabilitation, an expected average of three months
Secondary	Hand grip strength (JAMAR)		day 1 and at the end of the rehabilitation, an expected average of three months
Secondary	Fatigability: plate tapping test		day 1 and at the end of the rehabilitation, an expected average of three months
Secondary	Trunk Impairment Scale modified Norwegian version (TIS-modNV)		day 1 and at the end of the rehabilitation, an expected average of three months
Secondary	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
Secondary	International Physical Activity Questionnaire (IPAQ)		day 1 and at the end of the rehabilitation, an expected average of three months