Clinical trial NCT02339675: Psychometric Properties Upper Limb Function Measures Multiple Sclerosis
Official title: Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: Charles University, Czech Republic
name: Danish MS Hospitals, Haslev and Ry
name: Fondazione Don Carlo Gnocchi Onlus
name: Italian Multiple Sclerosis Foundation
name: centrisclerosimultipla
name: Sheba Medical Center
name: Haukeland University Hospital
name: MS Rehabilitation Center Borne Sulinowo
name: University of Ljubljana
name: Eugenia Epalza Rehabilitation Center, Bilbao, Spain
name: Day General Hospital.
name: Shepherd Center, Atlanta GA
name: Queen's University
name: St. Louis University
name: De Mick
name: MS center Hakadal AS
First posted: 2015-01-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Pinch strength
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Nine Hole Peg Test (NHPT)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Box and Block Test (BBT)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Coin rotation task (CRT)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Spasticity 0-10 numeric rating scale (NRS/VAS)
timeFrame: day 1, end of study
measure: Visual Analogue Scale muscle weakness
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Visual Analogue Scale sensory
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Visual Analogue Scale coordination
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Visual Analogue Scale fatigability
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Manual Ability Measurement (MAM-36)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: ABILHAND scale
timeFrame: day 1, end of study
measure: Performance Scale hand function (PS hand)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Upper Extremity Motor Activity Log (EU-MAL)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
Secondary outcomes:
measure: Hand grip strength (JAMAR)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Fatigability: plate tapping test
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Trunk Impairment Scale modified Norwegian version (TIS-modNV)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: day 1 and at the end of the rehabilitation, an expected average of three months
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Ilse Baert, dr.
role: STUDY_CHAIR
References: