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Completed

NCT Number: NCT02339675

Psychometric Properties Upper Limb Function Measures Multiple Sclerosis

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional MS rehabilitation

Other

assessment pre and post conventional MS rehabilitation

Primary outcomes

  1. Pinch strength

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Nine Hole Peg Test (NHPT)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. Box and Block Test (BBT)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  4. Coin rotation task (CRT)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  5. Spasticity 0-10 numeric rating scale (NRS/VAS)

    Time frame: day 1, end of study

  6. Visual Analogue Scale muscle weakness

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  7. Visual Analogue Scale sensory

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  8. Visual Analogue Scale coordination

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  9. Visual Analogue Scale fatigability

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  10. Manual Ability Measurement (MAM-36)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  11. ABILHAND scale

    Time frame: day 1, end of study

    a measure of manual ability for adults with upper limb impairment

  12. Performance Scale hand function (PS hand)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  13. 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 outcomes

  1. Hand grip strength (JAMAR)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Fatigability: plate tapping test

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. 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

  4. 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

  5. International Physical Activity Questionnaire (IPAQ)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • 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 ETS
  • Haukeland University Hospital
  • Italian Multiple Sclerosis Foundation
  • MS Rehabilitation Center Borne Sulinowo
  • MS center Hakadal AS
  • Queen's University
  • Revalidatie & MS Centrum Overpelt
  • Sheba Medical Center
  • Shepherd Center, Atlanta GA
  • St. Louis University
  • University of Ljubljana
  • centrisclerosimultipla

Registry information

Official study title

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

Acronym: MCS-III-UL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2015
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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