Psychometric Properties Upper Limb Function Measures Multiple Sclerosi

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

CompletedNot a drug-phase studyMS (type not specified)NCT02339675

What it found

No results found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • conventional MS rehabilitation

What it measured

Main measures

  • Pinch strength

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

    Physical function

  • Nine Hole Peg Test (NHPT)

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

  • Box and Block Test (BBT)

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

  • Coin rotation task (CRT)

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

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

    day 1, end of study

    Spasticity

  • Visual Analogue Scale muscle weakness

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

  • Visual Analogue Scale sensory

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

  • Visual Analogue Scale coordination

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

  • Visual Analogue Scale fatigability

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

  • Manual Ability Measurement (MAM-36)

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

  • ABILHAND scale

    day 1, end of study

    Arm and hand function

  • Performance Scale hand function (PS hand)

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

    Arm and hand function

  • Upper Extremity Motor Activity Log (EU-MAL)

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

    Arm and hand function

Other measures (5)

  • Hand grip strength (JAMAR)

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

    Arm and hand functionPhysical function

  • Fatigability: plate tapping test

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

  • Trunk Impairment Scale modified Norwegian version (TIS-modNV)

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

  • 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

    Arm and hand function

  • International Physical Activity Questionnaire (IPAQ)

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

    Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Oct 2014

    2. Main results due

      Feb 2016

    3. Finished

      Jun 2016

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