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

NCT07126730 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

EXOPULSE Mollii Suit + Exercise

First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Once patients put on the EXOPULSE Mollii Suit and the stimulation begins, they will undergo a personalized exercise program including strengthening, balance, and gait training with scheduled rest intervals. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks.

DEVICE

EXOPULSE Mollii Suit

First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Patients will wear the suit and receive stimulation while resting for 60 minutes. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Muhammed KILINÇ, Prof. Dr. · Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-01-01
Completion
2026-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126730 on ClinicalTrials.gov