Acute Effects of Wearable Electrical Stimulation in Stroke

March 10, 2026 updated by: Muhammed KILINÇ, Hacettepe University

Investigation of the Acute Effects of Wearable Electrical Stimulation on Spasticity, Upper and Lower Extremity Functions, and Gait in Individuals With Stroke

The goal of this clinical trial is to learn if the EXOPULSE Mollii Suit Wearable Electrical Stimulation works to reduce spasticity and improve functional capacity in individuals with stroke. It will also evaluate the acute (immediate) effects of the intervention.

The main questions it aims to answer are:

  1. Does wearable electrical stimulation reduce the severity of spasticity in participants?
  2. Does wearable electrical stimulation improve upper extremity performance, balance, and gait in participants?
  3. What impact does the intervention have on pain, fatigue, and overall satisfaction? Researchers will compare the EXOPULSE Mollii Suit treatment to a control group (who will wear the same suit but receive minimal electrical stimulation only on the neck and unaffected extremities) to see if it is effective in stroke rehabilitation.

Participants will:

  • Wear the EXOPULSE Mollii Suit and receive either the prescribed therapeutic level or a minimal level of electrical stimulation for a single 1-hour session.
  • Undergo clinical assessments (e.g., MAS, gait tests, functional mobility scales) administered by researchers immediately before and immediately after the application to evaluate spasticity, pain, fatigue, balance, gait, and hand functions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spasticity is one of the most significant motor impairments limiting functional capacity in stroke, occurring in approximately 20-30% of all stroke survivors. According to current approaches, spasticity is defined as a motor disorder characterized by a velocity- and muscle length-dependent increase in resistance to passive muscle stretch, resulting from hyperexcitable descending brainstem excitatory pathways and accompanying exaggerated stretch reflex responses. Post-stroke spasticity is often associated with pain, soft tissue stiffness, and joint contractures, which can lead to abnormal extremity posture, decreased quality of life, and increased treatment costs and caregiver burden. Early detection and management of post-stroke spasticity can not only reduce these complications but also improve function and increase independence.

In clinical practice, medical (local and general muscle relaxants, Botulinum Toxin A), surgical, and physiotherapy approaches are utilized for spasticity inhibition and modulation. Electrical stimulation has been applied for many years in various forms to manage spasticity. Surface electrical stimulation is a non-invasive therapeutic method used to increase muscle strength and passive range of motion, as well as to improve voluntary motor control by reducing pain and spasticity in patients with central nervous system involvement. However, optimal parameters for reducing spasticity remain a subject of debate in the literature. While conventional protocols often use high-frequency settings (2-100 Hz), studies also show low frequencies can be effective. Furthermore, the integration of electrical stimulation with wearable technologies has moved these applications beyond traditional clinical settings, providing ease of use, continuity, and personalized, targeted intervention options.

The EXOPULSE Mollii method (EXONEURAL NETWORK AB, Danderyd, Sweden) is an innovative approach for non-invasive, self-administered electrical stimulation utilizing multiple electrodes incorporated into a full-body suit. It is specifically designed to reduce spasticity and improve motor function in neurological disorders. The method's primary mechanism is based on reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. It is hypothesized that this stimulation reduces spasticity in the agonist muscle (e.g., elbow flexor) by stimulating the afferent nerve fibers of the antagonist muscle (e.g., elbow extensor), activating inhibitory Ia interneurons in the spinal cord, and thereby decreasing the excitability of the agonist motor neuron.

Additionally, similar to transcutaneous electrical nerve stimulation (TENS), the suit may induce neuroplastic changes in brain or spinal cord circuits. It is postulated that spasticity reduction is mediated by the activation of large-diameter sensory nerve afferents that modulate abnormal interneuron activities across several spinal segments. The suit utilizes 58 dry, embedded silicone electrodes, operating with a square wave pulse shape, a pulse width between 25-175 microseconds, and a constant current at a frequency of 20 Hertz.

Previous pilot studies evaluating the EXOPULSE Mollii method in patients with stroke or cerebral palsy have shown potential benefits. However, gaps remain in the literature due to the lack of control groups, absence of acute effect studies, and methodological variations. Therefore, the objective of this clinically controlled study is to investigate the acute effects of the EXOPULSE Mollii Suit on spasticity severity, pain, fatigue, upper and lower extremity functions, balance, gait, endurance, and hand functions in individuals with stroke. This is a clinically controlled trial. Individuals diagnosed with stroke will be assigned to either the treatment group or the control group.

Intervention Group: Participants will receive electrical stimulation via the EXOPULSE Mollii Suit for a single 1-hour session. The stimulation will be applied at a prescribed, therapeutic intensity through the embedded silicone electrodes based on the participant's specific functional impairments.

Control Group: Participants will wear the same EXOPULSE Mollii Suit for 1 hour; however, they will receive only minimal-intensity electrical stimulation restricted strictly to the neck and unaffected (non-paretic) extremities.

To evaluate the acute effects, all clinical assessments will be performed by a blinded researcher at two specific time points: immediately before donning the suit (baseline) and immediately after the 1-hour application.

The evaluation parameters will include:

  • Spasticity severity of upper and lower extremity muscles via the Modified Ashworth Scale (MAS), recorded via the Mollii Suit computer interface.
  • Pain, fatigue, and satisfaction levels using the Visual Analog Scale (VAS).
  • Hand performance using the 9-Hole Peg Test.
  • Functional capacity using the Stroke Rehabilitation Assessment of Movement (STREAM) scale.
  • Lower extremity functional level using the 5 Times Sit-to-Stand Test.
  • Functional mobility skills using the Timed Up and Go (TUG) Test.
  • Gait performance using the 10-Meter Walk Test.

Study Type

Interventional

Enrollment (Estimated)

26

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

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:

  • Aged 18 years and older
  • Diagnosed with stroke by a neurologist
  • Able to walk independently
  • Presence of spasticity (Modified Ashworth Scale [MAS] score > 1)
  • Mini-Mental State Examination (MMSE) score of 24 or higher.

Exclusion Criteria:

  • History of recurrent stroke
  • Difficulty or inability to don and doff the wearable device (e.g., due to severe obesity, mysophobia/hygiene obsession)
  • Received Botulinum toxin injections or underwent spasticity-related surgery within the past 6 months
  • Presence of any other neurological or orthopedic conditions (other than stroke) that would prevent participation in the study
  • Refusal to participate or failure to provide written informed consent.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active EXOPULSE Mollii Suit
Participants will wear the EXOPULSE Mollii Suit and receive electrical stimulation at the system-prescribed therapeutic intensity via 56 embedded electrodes for a single 1-hour session.
Device: EXOPULSE Mollii Suit
Before donning the Exopulse Mollii device, the spasticity levels in the affected muscle groups of the participants will be assessed using the Modified Ashworth Scale (MAS). In order to achieve reciprocal inhibition, values one degree higher than the obtained scores will be entered into the Exopulse Mollii system to correspond with the antagonists of the spastic muscles. Once the system generates a personalized current algorithm, this algorithm will be transferred to the control unit. The Exopulse Mollii Wearable Stimulation suit will then be put on the participant, and the individual will be placed in a resting position. Finally, the control unit will be attached to its designated place on the suit, and the algorithmic current determined by the system will be applied to the participant for a duration of 1 hour.
Sham Comparator: Sham EXOPULSE Mollii Suit
Participants will wear the EXOPULSE Mollii Suit but will receive only minimal-intensity electrical stimulation restricted to the neck and unaffected extremities for a single 1-hour session.
Device: EXOPULSE Mollii Suit with Sham Stimulation
Before donning the Exopulse Mollii device, the spasticity levels of the participants will be assessed using the Modified Ashworth Scale (MAS) to maintain the blinding of the study. The Exopulse Mollii Wearable Stimulation suit will then be put on the participant, and the individual will be placed in a resting position. The control unit will be attached to its designated place on the suit. However, unlike the active group, the system will be programmed to deliver only minimal-intensity electrical stimulation. This minimal current will be restricted strictly to the neck and unaffected extremities and will be applied to the participant for a duration of 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention.
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. A decrease in the score indicates an improvement in spasticity.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) Test
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention
The change in functional mobility will be assessed by using TUG Test. It measures the time, in seconds, it takes a participant to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. A shorter completion time indicates better functional mobility and balance.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention
10-Meter Walk Test (10MWT)
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention
The change in gait performance will be assessed by using 10-Meter Walk Test (10MWT). This test measures walking speed in meters per second over a short distance. The participant walks 10 meters, and the time is recorded. A shorter time (or higher speed) indicates better gait performance.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention
Five Times Sit-to-Stand Test
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention
The change in lower extremity functional level will be assessed by using Five Times Sit-to-Stand Test. It measures the amount of time, in seconds, a participant takes to stand up and sit down five times consecutively as quickly as possible. A shorter time indicates better lower extremity strength and functional level.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention
Nine-Hole Peg Test
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention
The change in hand performance will be assessed by using the Nine-Hole Peg Test (9HPT). It measures fine motor dexterity by timing how fast a participant can place nine pegs into a board and then remove them. A shorter completion time indicates better hand performance.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention
Visual Analog Scale (VAS) for pain and fatigue
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention
The changes in pain intensity and fatigue level will be assessed by using Visual Analog Scale (VAS). Participants rate their current level of pain/fatigue from 0 to 10 (or 0 to 100 mm), where higher scores indicate a higher level of pain/fatigue.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention
Visual Analog Scale (VAS)
Time Frame: Immediately after the 1-hour intervention
The treatment satisfaction will be assessed by using the VAS. It evaluates the participant's overall satisfaction with the wearable electrical stimulation intervention. Higher scores indicate greater satisfaction with the treatment.
Immediately after the 1-hour intervention
Stroke Rehabilitation Assessment of Movement (STREAM)
Time Frame: Baseline (immediately before the intervention) and immediately after the 1-hour intervention.
The change in functional capacity will be assessed by using STREAM scale. This scale evaluates voluntary movement and basic mobility following a stroke. It consists of 30 items across three subscales: upper limb movements, lower limb movements, and basic mobility. The minimum value is 0 and the maximum value is 70. Higher scores indicate better motor function and mobility.
Baseline (immediately before the intervention) and immediately after the 1-hour intervention.

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Muhammed KILINÇ, PT, PhD, Prof. Dr., Hacettepe University, Faculty of Physical Therapy and Rehabilitation
  • Principal Investigator: Eren KESKE, Hacettepe University, Faculty of Physical Therapy and Rehabilitation

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)

March 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTREK 24/07

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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