Unraveling Early Walking Dysfunction in Non-disabled MS People: Assess

Unraveling Early Walking Dysfunction in Non-disabled MS People: Clinical and Instrumental Assessment of Disease Progression and Potential Therapeutic Interventions

Status unknownNot a drug-phase studyMS (type not specified)NCT03492450

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Treadmill training

What it measured

Main measures

  • Change in Six Minutes Walking Test

    Change from Baseline 6 minutes walking test scores at 8 weeks

    Walking and mobility

  • Change in Instrumented variables

    Change from Baseline scores at 8 weeks

    Walking and mobility

Other measures (4)

  • the Twelve-Item Walking Scale

    Change from Baseline Twelve-Item Walking Scale scores at 8 weeks

    Walking and mobilityQuality of life (reported by participants)

  • the Twentyfive-foot walking test

    Change from Baseline Twentyfive-foot walking test scores at 8 weeks

    Walking and mobility

  • The Fatigue Severity Scale

    Change from Baseline Fatigue Severity Scale scores at 8 weeks

    FatigueQuality of life (reported by participants)

  • the Nine hole peg test

    Change from Baseline Nine Hole Peg test scores at 8 weeks

    Arm and hand function

Who could take part

MS (type not specified) · 18 to 80

Show the full criteria

Inclusion criteria

* Included will be patients residing in the centers' catchment areas * Diagnosis of Multiple Sclerosis (Polman criteria) * Stable disease course without worsening more than 1 Expanded Disability Status Scale (EDSS) point over the last 3 months * EDSS \< 2.5, * Disease duration shorter than or equal to 5 years, * Releasing a written informed consent.

Exclusion criteria

* Multiple Sclerosis relapse within the previous three months * Cognitive impairment (MMSE score \<27); * Diagnosis of major depression (DSM-IV); * Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * Cardiovascular diseases; * Unconfirmed or uncertain diagnosis of MS (Polman criteria) * Other concomitant neurological diseases;

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

About this trial

In the sponsor's words

The aim of the study is to set up a pilot study to investigate the effects of treadmill training in preventing the onset and worsening of walking impairments, balance deficits and fatigue.

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History

    1. Started

      May 2018

    2. Main results due

      Dec 2019

    3. Finished

      Jun 2020

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