Acute Effects of Wearable Electrical Stimulation in Stroke (NCT07459361) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acute Effects of Wearable Electrical Stimulation in Stroke
26 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Ashworth Scale (MAS)
Timeframe: Baseline (immediately before the intervention) and immediately after the 1-hour intervention.