Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis

January 9, 2026 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital

Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis

  • Objective assessment of clinical symptoms resulting from stroke, as well as changes in mobility and quality of life, and determination of changes resulting from therapies
  • Objective assessment of the quality of life, functionality, and clinical symptoms of patients with multiple sclerosis (MS) and determination of changes resulting from therapies
  • Comparison of measured data from the two main neurological patient groups (stroke, multiple sclerosis) and follow-up of changes in relation to themselves and each other.
  • Mapping the role of the placebo effect in neuromodulation devices by comparing subjective and objective outcomes.
  • Analyzing the expectations and experiences of patients receiving placebo treatment using quality of life questionnaires.
  • Analyzing the effects of the Mollii suit among subgroups of MS and stroke patients.
  • Assessing the safety, possible side effects, and tolerability of the Mollii suit.
  • Mapping changes in gait pattern due to the effects of therapy using 3D motion analysis.
  • Examining the maintenance effects of neuromodulation during a 1-month follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Recruiting
        • Somogy County Kaposi Mor Teaching Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • suffered a first ischemic stroke, diagnosed by a neurologist based on CT or MR imaging
  • neurological examination revealed mobility and postural limitations
  • confirmed multiple sclerosis diagnosed by a neurologist based on MRI imaging

Exclusion Criteria:

  • multiple strokes in medical history
  • systolic blood pressure less than 120 or higher than 160 mmHg
  • orthostatic hypotension
  • arotid artery stenosis
  • severe heart disease
  • hemophilia
  • traumatic brain injury
  • seizure disorder
  • untreated diabetes
  • abnormal electroencephalography
  • abnormal blood panel
  • use of sedatives
  • irregular medication use
  • severe aphasia (Western Aphasia Battery ≤ 25)
  • severe visual or hearing impairment
  • severe sensory dysfunction
  • severe orthopedic problems
  • other neurological conditions affecting motor function
  • alcoholism
  • drug use
  • smoking after diagnosis of stroke
  • unable to walk at least 10 m with or without assistance in 6 minutes
  • BBS score ≤ 32
  • BI score ≤ 70
  • current participation in individual or group exercise program outside of standard physical therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mollii Group
Receaving treatment with the stimulation program.
Other: the Mollii garment with active stimulation
Patients in the Intervention group attend therapy three days a week for four weeks, with each treatment lasting 60 minutes. In this group patients are fitted with the Mollii garment according to the same protocol, but in their case, active stimulation of the prescribed neuromodulation program is initiated.
Placebo Comparator: Control Group
Receaving treatment without the stimulation program.
Other: Mollii neuromodulation garment, but the stimulation program is not activated (placebo)
CG patients are fully equipped with the Mollii neuromodulation garment, but the stimulation program is not activated. The patient thus completes the therapy without the device's perceptible electrical stimulation, preserving the blinding effect of the placebo-controlled setup. The total treatment time, setup process, and therapeutic environment are the same as for the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: 4 weeks
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
4 weeks
Barthel Index (BI)
Time Frame: 4 weeks
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale (SIS)
Time Frame: 4 weeks
Physical and psychological functions after stroke scaling 0-100 points, higher score means better post-stroke functions.
4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: 4 weeks
Physical and psychological effects in MS, scaling 0-100 points, where higher scores mean greater disease impact.
4 weeks
Berg Balance Scale (BBS)
Time Frame: 4 weeks
Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.
4 weeks
Tinetti
Time Frame: 4 weeks
Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.
4 weeks
Timed Up and Go (TUG)
Time Frame: 4 weeks
Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.
4 weeks
6 minute walk test (6MWT)
Time Frame: 4 weeks
Functional exercise capacity
4 weeks
10 meter walk test (10mWT)
Time Frame: 4 weeks
Walking speed
4 weeks
Posturographic examination
Time Frame: 4 weeks
Postural instability
4 weeks
3D motion analysis
Time Frame: 4 weeks
Movement dynamics, gait
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Investigators

  • Principal Investigator: József Dr. habil Tollár, Somogy County Kaposi Mor Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IG/4390-0/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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