Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study

CompletedNot a drug-phase studyMS (type not specified)NCT03860675

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Assessment of walking-related fatigability

What it measured

Main measures

  • Deceleration index

    day 1

    Walking and mobility

Other measures (15)

  • Symptom Inventory Questionnaire

    day 1

    Thinking and memoryFatigueWalking and mobilitySpasticityPain
  • Symptom Inventory Questionnaire

    day 4

    Thinking and memoryFatigueWalking and mobilitySpasticityPain
  • spasticity

    day 1

    Walking and mobilitySpasticity
  • spasticity

    day 4

    Walking and mobilitySpasticity
  • Strength

    day 1

    Walking and mobilityPhysical function
  • Strength

    day 4

    Walking and mobilityPhysical function
  • Balance

    day 1

    Walking and mobility
  • Balance

    day 4

    Walking and mobility
  • VAS fatigue

    day 1

    FatigueWalking and mobility
  • VAS fatigue

    day 4

    FatigueWalking and mobility

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Age between 18 - 70 years * Confirmed diagnosis according to the McDonald criteria * Performed a 6MWT before, to ensure familiarization * Able to walk independently or with unilateral support for 6 minutes without rest * Signed the informed consent

Exclusion criteria

* Exacerbation or relapse within last 3 months before study * Other neurological diagnosis, such as stroke and Parkinson * MS-like syndromes, such as neuromyelitis optica * Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)

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

About this trial

In the sponsor's words

The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability. The following three research questions will be addressed: 1. How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure? 2. What are associated symptoms of walking-related motor fatigability and how long does this manifest? 3. What is the relationship between cognitive fatigability and walking-related performance fatigability? participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.

Papers

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History

    1. Started

      Dec 2017

    2. Main results due

      May 2018

    3. Finished

      May 2018

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