Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B

Status unknownNot a drug-phase studyMS (type not specified)NCT06056960

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Tailored Physical Activity

What it measured

Main measures

  • Fatigue Severity Scale (FSS)

    Baseline, Post, FollowUp_6month

    Fatigue

Other measures (4)

  • Differences in oxygenated hemoglobin (Delta oxyHb)

    Baseline, Post, FollowUp_6month

  • Six Minute walking test (6MWT)

    Baseline, Post, FollowUp_6month

    Walking and mobility
  • Number of steps/day

    Baseline, Post, FollowUp_6month

  • Endurance walking capacity

    Baseline, Post, FollowUp_6month

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Age > 17 years * Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)

Exclusion criteria

* Major depression * Mini-Mental State Examination \< 27 * Other cardiovascular or orthopedic diseases that interfere with physical exercise * Progressive course of the disease

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

About this trial

In the sponsor's words

It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity. There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity. To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.

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History

    1. Started

      Jul 2024

    2. Main results due

      Jan 2025

    3. Finished

      Jan 2025

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