MSFrontier

Telerehabilitation in Progressive Multiple Sclerosis

The Effectiveness of Combining a Home-based Digital Motor Telerehabilitation Program With Conventional Therapy in Progressive Multiple Sclerosis: a Multicentre, Randomized Controlled Trial
Status unknownNot a drug-phase studyProgressive MSNCT06485115

What it found

Result in a paper, not read yet

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

What was tested

Treatment tested

  • Digital Telerehabilitation (Euleria Home)
  • Conventional therapy

What it measured

Main measures

  • Change in the Timed Up and Go test

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Walking and mobility

Other measures (44)

  • Change in the Multiple Sclerosis Functional Composite (MSFC)

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Disability progressionThinking and memoryWalking and mobilityArm and hand function

  • Mental workload through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Disability progressionNerve conduction tests

  • Vigilance state through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Disability progressionNerve conduction tests

  • Surface electromyography (EMG) during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Disability progressionArm and hand function

  • Inertial Measurement Unit (IMU) system during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Disability progressionArm and hand function

  • Change in the Fatigue Severity Scale (FSS)

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Fatigue

  • Change in the Activities-specific balance confidence (ABC)

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Walking and mobility

  • Change in the Manual Ability Measure-36 (MAM-36)

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Arm and hand function

  • The number of falls in the previous month

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Walking and mobility

  • Timed Up and Go (TUG) test - Cognitive

    Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks af

    Thinking and memoryWalking and mobility

Who could take part

Progressive MS · 18 to 75

Inclusion Criteria: * Age 18-75; * Diagnosis of MS (primary or secondary progressive); * Mild to moderate balance impairments with increased fall risk, defined as TUG > 8.4s; * A disability rate, as calculated using the Kurtzke Expanded Disability Status Scale (EDSS) lower than 7; * Acceptable level of digital skills; * The presence of the caregiver. Exclusion Criteria: * Other conditions that may affect motor function; * Impaired cognitive functioning (Mini-Mental Status Examination \<24/30); * Severe visual deficits (daltonism and visual acuity deficit); * Unable or refused to attend the rehabilitation treatment. Patients who fulfill the following specified inclusion criteria will also undergo an EEG evaluation. However, ineligibility for this examination does not exclude them from participating in the rehabilitation study. The inclusion criteria for the EEG protocol will include: * The absence of metallic implants in the brain; * No history of brain surgery; * No use of medications that alter cortical excitability or are presumed to affect brain plasticity; * Right-handed dominance.

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a highly disabling chronic, inflammatory, demyelinating disease of the Central Nervous System (CNS). Significant progress has been made during the past three decades in managing the relapsing-remitting phase of Multiple Sclerosis (RRMS). However, once patients have entered the progressive stage of MS (secondary progressive, SPMS), therapeutic options are limited to symptomatic treatments and rehabilitation. In addition, 10-20% of patients experience unremitting disease progression (primary progressive MS, or PPMS). The limited research focusing on Progressive MS (PMS) and the lack of ecological validity highlight the need for a bolder approach that combines more than one intervention intending to produce synergistic effects. The primary aim is to test the effectiveness of combining a home-based Digital Telerehabilitation program with in-hospital rehabilitation on mobility against in-hospital rehabilitation alone.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jun 2024

    2. Main results due

      Jun 2026

    3. Finished

      Jun 2026

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