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

H

Hasselt University

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: conventional MS rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02339675
ML10456-S56575

Details and patient eligibility

About

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).

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

136 participants in 1 patient group

convential MS rehabilitation
Other group
Description:
Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function
Treatment:
Other: conventional MS rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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