Effects of EXOPULSE Mollii Suit on Spasticity and Functionality in Mul

Investigating the Effects of the EXOPULSE Mollii Suit on Spasticity and Functionality in Patients With Multiple Sclerosis

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07126730

What it found

Still running

No result yet.

What was tested

Treatment tested

  • EXOPULSE Mollii Suit + Exercise

Compared with

  • EXOPULSE Mollii Suit

What it measured

Main measures

  • Modified Ashworth Scale (MAS)

    4 weeks

    Spasticity

  • Berg Balance Scale (BBS)

    4 weeks

    Walking and mobility

  • OptoGait Gait Analysis System

    4 weeks

    Walking and mobility

Other measures (10)

  • EDSS (Expanded Disability Status Scale)

    4 weeks

    Disability progressionBladder, bowel and sexual function

  • Visual Analog Scale (VAS) for pain and fatigue

    4 weeks

    FatiguePain

  • Fatigue Severity Scale

    4 weeks

    Fatigue

  • 9-Hole Peg Test

    4 weeks

    Disability progressionArm and hand function

  • 5 Times Sit to Stand Test

    4 weeks

    Physical function

  • Timed Up and Go (TUG) Test

    4 weeks

    Walking and mobility

  • 10 meter Walk Test

    4 weeks

    Walking and mobility

  • 12-Item Multiple Sclerosis Walking Scale

    4 weeks

    Walking and mobility

  • Functional Independence Measure (FIM)

    4 weeks

    Walking and mobility

  • Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    4 weeks

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosed with MS by a neurologist according to McDonald criteria * Age >18 years * EDSS score ≤6.5 (able to walk independently without assistive devices) * Presence of spasticity * Mini Mental State Examination (MMSE) score ≥24

Exclusion criteria

* Received surgical intervention or botulinum toxin injection for spasticity within the last 6 months * Presence of any neurological condition (other than MS) that may affect independent standing or walking * Currently participating in another rehabilitation program * Declined to participate or provide written informed consent

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

Contact details on the registry

About this trial

In the sponsor's words

Spasticity affects >80% of MS patients, with 35-54% experiencing moderate-to-severe symptoms, impairing mobility and sleep. Electrical stimulation parameters (e.g., high vs. low frequency) for spasticity management remain debated. The EXOPULSE Mollii Suit uses non-invasive, low-frequency stimulation to induce reciprocal inhibition and modulate spinal interneuron activity, potentially reducing spasticity. This study aims to compare EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone in improving spasticity and function in MS.

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History

    1. Started

      Sept 2025

    2. Main results due

      Jan 2026

    3. Finished

      Feb 2026

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