Acute Effects of Wearable Electrical Stimulation in Stroke

NCT07459361 | Not Yet Recruiting

• 1 other identifier: FTREK 24/07
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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.

Conditions

Stroke

Keywords

spasticity

Outcome Measures

Primary Outcomes (1)

• 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. A decrease in the score indicates an improvement in spasticity.

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention.

Secondary Outcomes (7)

• Stroke Rehabilitation Assessment of Movement (STREAM)

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention.

• Timed Up and Go (TUG) Test

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention

• 10-Meter Walk Test (10MWT)

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention

• Five Times Sit-to-Stand Test

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention

• Nine-Hole Peg Test

  Baseline (immediately before the intervention) and immediately after the 1-hour intervention

Study Arms (2)

Active EXOPULSE Mollii Suit

EXPERIMENTAL

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

Sham EXOPULSE Mollii Suit

SHAM COMPARATOR

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

Interventions

EXOPULSE Mollii Suit DEVICE

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.

Active EXOPULSE Mollii Suit

EXOPULSE Mollii Suit with Sham Stimulation DEVICE

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.

Sham EXOPULSE Mollii Suit

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özge ONURSAL, PhD

CONTACT

+903123051576; ozgeonursal@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 15, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share