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Completed

NCT Number: NCT06702163

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.

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Key information

Conditions

Spasticity as Sequela of Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

Créteil, VAL DE MARNE, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years.
  • Having a clinical diagnosis of stroke for at least three months.
  • Being able to walk freely or with the need of support (modified Rankin score
  • 4).
  • Being a French speaker, able to understand verbal instructions, and affiliated. with the national health insurance (sécurité social).
  • Having spasticity with a score of at least 1+ on the MAS.
  • Having a Berg Balance Scale score ≤46 associated across the literature with a risk of fall.

Exclusion criteria

  • Being included in another research protocol during the study period.
  • Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
  • Having contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
  • Being pregnant (confirmed by a blood beta-HCG test).
  • Having a change in their pharmacological therapy in the last three months.
  • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
  • Having a body mass index above 35 Kg/m2.
  • In case of introducing a medical device other than EXOPULSE Mollii suit during the study period.
  • Patients under juridical protection (" mesure de protection) judiciare : tutelle, curatelle, sauvegarde de justice ")
  • Patients deprived of freedom (" personnes privées de liberté ".)

Treatment and study plan

EXOPULSE MOLLII SUIT (active)

Device

Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company.

Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. This stimulation is not intended to obtain a motor effect (contraction of the muscles in question), but rather to decrease the spasticity in spastic muscles by activating the antagonistic muscles via the physiological mechanism of reciprocal inhibition. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more.

EXOPULSE MOLLII SUIT (sham)

Device

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Primary outcomes

  1. Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation

    Time frame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)

    Balance will be assessed using the 14-item BBS which has good psychometric properties in patients with stroke. The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.

Secondary outcomes

  1. Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)

    Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit

    The cumulative effects of EXOPULSE Mollii Suit will be assessed following 4 weeks of using the device (3-4 times per week, during the open-label phase 2)

  2. Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)

    Time frame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

    Spasticity will be evaluated by examiners using the MAS (Modified Ashworth Scale) and by patients using a VAS (Visual Analogue Scale)

  3. Mobility will be assessed using the TUG scale (Time Up and Go)

    Time frame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)

    TUG (Time Up and Go)is a validated test in patients with stroke. The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace and finally sitting down).

  4. Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)

    Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)

    Subjective risk of fall will be assessed using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling.

  5. Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)

    Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)

    This variable will be measured using the EuroQol 5 dimensions quality of life questionnaire, a scale developed by EuroQoL group. This scale has good psychometric properties in stroke and seems to be the most used generic health status questionnaire in this population. The 5 levels version (EQ-5D-5L) will be adopted in this work. The scale evaluates five dimensions: anxiety/depression, mobility, pain/difficulty, self-care, and usual activities.

  6. Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)

    Time frame: This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6)

    The visual analog scale for pain is a 10 mm straight line with one end meaning no pain and the other end meaning the worst pain imaginable

  7. Evaluation of overall improvement using the CGI (Clinical Global Impression)

    Time frame: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions

    It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)

  8. Evaluation of patient's blinding to the type of stimulation in the crossover trial

    Time frame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) since it's designed to be applied after interventions of phase 1 (double blind phase)

    This blind evaluation will be done in phase 1 using a dedicated questionnaire (only at visits 2 and 4 after each condition, as all patients will receive the same active treatment during open-label phase 2).

Sponsors and collaborators

Lead sponsor

Institut De La Colonne Vertebrale Et Des Neurosciences

Other

Registry information

Official study title

The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)

Acronym: EXOSTROKE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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