Underlying Causes and Related Factors, and Rehabilitation Approaches

Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o

CompletedNot a drug-phase studyMS (type not specified)NCT04142853

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

  • Training intervention + Dance intervention

What it measured

Main measures

  • the Coordination test

    Day 1

  • TST (Triple Stimulation Technique)

    day 3

  • TMS (Transcranial Magnetic Stimulation)

    Day 3

    Nerve conduction tests

  • the Voluntary Drive test

    Day 1

  • the Fatigability Index Legs

    Day 1

    Physical function

  • Analysis of a Muscle Biopsy

    Day 3

  • the Digit Span

    Baseline

    Thinking and memory

  • the Digit Span

    Week 11

    Thinking and memory

  • the Stroop test

    Baseline

    Thinking and memory

  • the Stroop test

    week 11

    Thinking and memory

  • the Paced Auditory Serial Addition Test (PASAT)

    Baseline

    Thinking and memory

  • the Paced Auditory Serial Addition Test (PASAT)

    Week 11

    Thinking and memory

  • the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)

    Baseline

    Thinking and memory

  • the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)

    week 11

    Thinking and memory

  • Motor function test (lower limb muscle strength)

    Baseline

    Physical function

  • Motor function test (lower limb muscle strength)

    week 11

    Physical function

  • 25 Foot Walk (T25FW) test

    Baseline

    Disability progressionWalking and mobility

  • 25 Foot Walk (T25FW) test

    week 11

    Disability progressionWalking and mobility

  • Nine Hole Peg Test (NHPT)

    Baseline

  • Nine Hole Peg Test (NHPT)

    week 11

  • Fatigability Index Hand

    Baseline

    Arm and hand functionPhysical function

  • Fatigability Index Hand

    week 11

    Arm and hand functionPhysical function

  • Activity tracker

    Up to 5 days

    Physical functionMood and sleep

  • Glycocheck

    Baseline

  • Six minute walking test

    once during the observational study

    Walking and mobility

Other measures (20)

  • Fatigue severity scale (FSS)

    baseline

    Fatigue

  • Fatigue severity scale (FSS)

    week 11

    Fatigue

  • Modified Fatigue Impact Scale (MFIS)

    baseline

    Thinking and memoryFatigue

  • Modified Fatigue Impact Scale (MFIS)

    week 11

    Thinking and memoryFatigue

  • Fatigue Scale of Motor and Cognitive Functions (FSMC)

    baseline

    Thinking and memoryFatigue

  • Fatigue Scale of Motor and Cognitive Functions (FSMC)

    week 11

    Thinking and memoryFatigue

  • Hospital Anxiety and Depression Scale (HADS)

    baseline

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Week 11

    Mood and sleep

  • The Sleep Condition Indicator (SCI)

    baseline

    Mood and sleep

  • The Sleep Condition Indicator (SCI)

    week 11

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Age between 18 and 70 years. * MS diagnosis according to McDonald Criteria. * Capable of walking 6 minutes (independent or with unilateral support) without stopping.

Exclusion criteria

* Exacerbation or relapse within last 3 months before study * Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).

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

About this trial

In the sponsor's words

This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance fatigability.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2019

    2. Main results due

      Dec 2019

    3. Finished

      Dec 2019

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