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

NCT07126730 | Not Yet Recruiting

• 1 other identifier: FTREK25/78
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Multiple Sclerosis

Keywords

spasticity; delete

Outcome Measures

Primary Outcomes (3)

• Modified Ashworth Scale (MAS)

  Spasticity in patients will be assessed using the Modified Ashworth Scale (MAS). It grades spasticity based on the resistance exhibited by the muscle, using a scale of 0, 1, 1+, 2, 3, and 4.

  4 weeks

• Berg Balance Scale (BBS)

  This 14-item scale is scored from 0 to 4 for each item. A score of 0 indicates inability to perform, while a score of 4 indicates normal performance. With a maximum total score of 56, higher scores indicate better balance ability.

  4 weeks

• OptoGait Gait Analysis System

  During the test, the patient is asked to step onto the treadmill. They are then asked to adjust the treadmill speed to their preferred pace and walk for one minute. While walking on the treadmill, objective data related to their gait's time-distance characteristics is obtained. The evaluation takes five minutes.

  4 weeks

Secondary Outcomes (10)

• EDSS (Expanded Disability Status Scale)

  4 weeks

• Visual Analog Scale (VAS) for pain and fatigue

  4 weeks

• Fatigue Severity Scale

  4 weeks

• 9-Hole Peg Test

  4 weeks

• 5 Times Sit to Stand Test

  4 weeks

Study Arms (2)

EXOPULSE Mollii + Exercise

EXPERIMENTAL

During the 60-minute EXOPULSE Mollii stimulation session, patients will also perform a guided exercise program.

Device: EXOPULSE Mollii Suit + Exercise

EXOPULSE Mollii

ACTIVE COMPARATOR

For 60 minutes, patients will only receive stimulation while wearing the EXOPULSE Mollii suit.

Device: EXOPULSE Mollii Suit

Interventions

EXOPULSE Mollii Suit + Exercise DEVICE

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.

EXOPULSE Mollii + Exercise

EXOPULSE Mollii Suit DEVICE

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.

EXOPULSE Mollii

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Muhammed KILINÇ, Prof. Dr.

  Hacettepe University, Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özge ONURSAL KILINÇ, PhD

CONTACT

+903123051576; ozgeonursal@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share