Acute Effects of Wearable Electrical Stimulation in Stroke

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:

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.

Conditions

• Stroke

Interventions

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.

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.

Sponsors & Collaborators

• Hacettepe University

  lead OTHER

Principal Investigators

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

• Eren KESKE · Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2026-06-15

Completion

2026-06-30