Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:22 AM
Study NCT ID:
NCT07459361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Wearable Electrical Stimulation in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Stroke Rehabilitation Assessment of Movement (STREAM)', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention.', 'description': '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.'}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention', 'description': '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.'}, {'measure': '10-Meter Walk Test (10MWT)', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention', 'description': '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.'}, {'measure': 'Five Times Sit-to-Stand Test', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention', 'description': '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.'}, {'measure': 'Nine-Hole Peg Test', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention', 'description': '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.'}, {'measure': 'Visual Analog Scale (VAS) for pain and fatigue', 'timeFrame': 'Baseline (immediately before the intervention) and immediately after the 1-hour intervention', 'description': '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.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Immediately after the 1-hour intervention', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spasticity'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n1. Does wearable electrical stimulation reduce the severity of spasticity in participants?\n2. Does wearable electrical stimulation improve upper extremity performance, balance, and gait in participants?\n3. 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.\n\nParticipants will:\n\n* 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.\n* 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.', 'detailedDescription': "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.\n\nIn 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.\n\nThe 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.\n\nAdditionally, 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.\n\nPrevious 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.\n\nIntervention 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.\n\nControl 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.\n\nTo 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.\n\nThe evaluation parameters will include:\n\n* Spasticity severity of upper and lower extremity muscles via the Modified Ashworth Scale (MAS), recorded via the Mollii Suit computer interface.\n* Pain, fatigue, and satisfaction levels using the Visual Analog Scale (VAS).\n* Hand performance using the 9-Hole Peg Test.\n* Functional capacity using the Stroke Rehabilitation Assessment of Movement (STREAM) scale.\n* Lower extremity functional level using the 5 Times Sit-to-Stand Test.\n* Functional mobility skills using the Timed Up and Go (TUG) Test.\n* Gait performance using the 10-Meter Walk Test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and older\n* Diagnosed with stroke by a neurologist\n* Able to walk independently\n* Presence of spasticity (Modified Ashworth Scale \\[MAS\\] score \\> 1)\n* Mini-Mental State Examination (MMSE) score of 24 or higher.\n\nExclusion Criteria:\n\n* History of recurrent stroke\n* Difficulty or inability to don and doff the wearable device (e.g., due to severe obesity, mysophobia/hygiene obsession)\n* Received Botulinum toxin injections or underwent spasticity-related surgery within the past 6 months\n* Presence of any other neurological or orthopedic conditions (other than stroke) that would prevent participation in the study\n* Refusal to participate or failure to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT07459361', 'briefTitle': 'Acute Effects of Wearable Electrical Stimulation in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Acute Effects of Wearable Electrical Stimulation on Spasticity, Upper and Lower Extremity Functions, and Gait in Individuals With Stroke', 'orgStudyIdInfo': {'id': 'FTREK 24/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active EXOPULSE Mollii Suit', 'description': '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.', 'interventionNames': ['Device: EXOPULSE Mollii Suit']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham EXOPULSE Mollii Suit', 'description': '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.', 'interventionNames': ['Device: EXOPULSE Mollii Suit with Sham Stimulation']}], 'interventions': [{'name': 'EXOPULSE Mollii Suit', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Active EXOPULSE Mollii Suit']}, {'name': 'EXOPULSE Mollii Suit with Sham Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sham EXOPULSE Mollii Suit']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Özge ONURSAL, PhD', 'role': 'CONTACT', 'email': 'ozgeonursal@hacettepe.edu.tr', 'phone': '+903123051576', 'phoneExt': '183'}], 'overallOfficials': [{'name': 'Muhammed KILINÇ, PT, PhD, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation'}, {'name': 'Eren KESKE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Muhammed KILINÇ', 'investigatorAffiliation': 'Hacettepe University'}}}}