Multiple SclerosisNCT07126730
Effects of EXOPULSE Mollii Suit on Spasticity and Functionality in Multiple Sclerosis Patients
A study testing EXOPULSE Mollii Suit + Exercise and EXOPULSE Mollii Suit in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Spasticity affects >80% of MS patients, with 35-54% experiencing moderate-to-severe symptoms, impairing mobility and sleep. Electrical stimulation parameters (e.g., high vs. low frequency) for spasticity management remain debated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- EXOPULSE Mollii Suit + Exercise and EXOPULSE Mollii Suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MS by a neurologist according to McDonald criteria
- Age >18 years
- EDSS score ≤6.5 (able to walk independently with or without assistive devices)
- Presence of spasticity
- Mini Mental State Examination (MMSE) score ≥24
Who cannot join
- Received surgical intervention or botulinum toxin injection for spasticity within the last 6 months
- Presence of any neurological condition (other than MS) that may affect independent standing or walking
- Currently participating in another rehabilitation program
- Declined to participate or provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: Investigating the Effects of the EXOPULSE Mollii Suit on Spasticity and Functionality in Patients With Multiple Sclerosis
Spasticity affects >80% of MS patients, with 35-54% experiencing moderate-to-severe symptoms, impairing mobility and sleep. Electrical stimulation parameters (e.g., high vs. low frequency) for spasticity management remain debated. The EXOPULSE Mollii Suit uses non-invasive, low-frequency stimulation to induce reciprocal inhibition and modulate spinal interneuron activity, potentially reducing spasticity. This study aims to compare EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone in improving spasticity and function in MS.
Read the detailed description
Spasticity is one of the most common symptoms in multiple sclerosis (MS) patients. Large-scale surveys indicate that over 80% of MS patients experience spasticity during their disease course, with 35-54% reporting moderate to severe spasticity. Spasticity, particularly in the lower extremities, is associated with stiffness, spasms, and pain and negatively affects walking, stair climbing, and sleep. While electrical stimulation is a potential treatment for spasticity, optimal stimulation parameters remain unclear. The most commonly used protocol involves high-frequency stimulation (~100 Hz), though some studies suggest low-frequency stimulation may also be effective.
The EXOPULSE Mollii suit (EXONEURAL NETWORK AB, Danderyd, Sweden) is a non-invasive, self-administered electrical stimulation system with integrated electrodes. It is designed to reduce spasticity and improve motor function in neurological disorders. The method is based on reciprocal inhibition, where low-frequency, low-intensity stimulation of antagonist muscles activates Ia inhibitory interneurons, reducing spasticity in agonist muscles. Additional mechanisms may include neuroplastic changes in spinal or brain circuits, similar to transcutaneous electrical nerve stimulation (TENS). This study aims to compare the effects of EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone on spasticity and functionality in MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- EXOPULSE Mollii Suit + Exercise, EXOPULSE Mollii Suit
- Keywords
- spasticity, delete
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii Suit + ExerciseDevice
First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Once patients put on the EXOPULSE Mollii Suit and the stimulation begins, they will undergo a personalized exercise program including strengthening, balance, and gait training with scheduled rest intervals. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks.
EXOPULSE Mollii SuitDevice
First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Patients will wear the suit and receive stimulation while resting for 60 minutes. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks.
| Study group | Role | What they receive |
|---|---|---|
| EXOPULSE Mollii + Exercise | Experimental | During the 60-minute EXOPULSE Mollii stimulation session, patients will also perform a guided exercise program. Receives: Device: EXOPULSE Mollii Suit + Exercise |
| EXOPULSE Mollii | Active comparator | For 60 minutes, patients will only receive stimulation while wearing the EXOPULSE Mollii suit. Receives: Device: EXOPULSE Mollii Suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Berg Balance Scale (BBS)
This 14-item scale is scored from 0 to 4 for each item. A score of 0 indicates inability to perform, while a score of 4 indicates normal performance. With a maximum total score of 56, higher scores indicate better balance ability.
Measured: 4 weeks
OptoGait Gait Analysis System
During the test, the patient is asked to step onto the treadmill. They are then asked to adjust the treadmill speed to their preferred pace and walk for one minute. While walking on the treadmill, objective data related to their gait's time-distance characteristics is obtained. The evaluation takes five minutes.
Measured: 4 weeks
Secondary outcomes (10)
EDSS (Expanded Disability Status Scale)
The severity of the disease will be assessed using the Expanded Disability Status Scale (EDSS). This assessment is based on a clinician's interview and the patient's neurological status. A score of 0 represents normal neurological status, while a score of 10 indicates worsening MS. The next score after 0 is 1, and clinical deterioration is expressed in 0.5-point increments thereafter. The EDSS score is calculated using a rating scale of 0.0 to 4.0 for pyramidal, cerebellar, brainstem, sensory, visual, bowel-bladder, and mental functions. The rating is based on the patient's best performance without excessive effort. A score of 0-4 indicates independence; 6.0, unilateral support; 6.5, bilateral support; and 7.0 or higher, dependence.
Measured: 4 weeks
Visual Analog Scale (VAS) for pain and fatigue
The Visual Analog Scale will be used to assess pain and fatigue. Patients will rate their pain and fatigue on a 10-cm line. "No pain-no fatigue" will be scored as 0 points, and "the worst pain imaginable-the worst fatigue" will be scored as 10 points.
Measured: 4 weeks
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a nine-item scale that measures the severity of fatigue and its impact on patients' activities and lifestyle. Each item is scored on a scale from 1 to 7. A score of 1 indicates strong disagreement with the statement, while a score of 7 indicates strong agreement. The lowest possible total score is 7, and the highest possible total score is 63. The higher the score, the greater the fatigue severity.
Measured: 4 weeks
9-Hole Peg Test
A nine-hole peg test will be used to evaluate hand function. The time it takes individuals to insert and remove the nine pegs from the holes will be recorded. Participants will perform the test with both their dominant and non-dominant hands.
Measured: 4 weeks
5 Times Sit to Stand Test
Functional strength of the lower extremities will be assessed using the Five Times Sit-to-Stand Test. For this test, a standard-sized chair with a backrest (43-45 cm) is used. The patient sits on the chair with their back against the backrest. Each repetition of sitting down and standing up is counted. The time it takes to complete five repetitions is recorded using a stopwatch.
Measured: 4 weeks
Timed Up and Go (TUG) Test
The TUG test measures functional mobility skills and risk of falling. For this test, participants stand up from a chair, walk three meters, turn around, walk back, and sit down again. The time it takes to complete this task is used to determine functional mobility. Completing the task in ≤10 seconds indicates normal functional mobility. Completing it in <20 seconds indicates good mobility, meaning the individual can walk without assistive devices and go out alone. Completing it in <30 seconds indicates a mobility issue, meaning the individual needs to use assistive devices and cannot go out alone.
Measured: 4 weeks
10 meter Walk Test
A 10-meter walking test will be performed to evaluate patients' walking ability. Participants will walk 10 meters, and their time will be recorded with a stopwatch. The average time will be calculated based on three repetitions. Walking speed (m/s) will be calculated by dividing the walking distance (10 meters) by the average time obtained. Walking speeds are categorized as follows: <0.4 m/s indicates ambulation within the home, 0.4-0.8 m/s indicates limited ambulation outside the home, and >0.8 m/s indicates ambulation outside the home.
Measured: 4 weeks
12-Item Multiple Sclerosis Walking Scale
It assesses the patient's walking abilities over the past two weeks from their perspective. Each question is scored on a five-point scale. Patients are asked to rate themselves as follows: 1 = none; 2 = slight; 3 = moderate; 4 = severe; and 5 = very severe. A high score indicates difficulty walking.
Measured: 4 weeks
Functional Independence Measure (FIM)
Activities daily living will be assessed using the Functional Independence Measure (FIM). The FIM consists of 18 items that cover self-care, sphincter control, mobility, movement, communication, and social interaction. Scores range from 18 to 126.
Measured: 4 weeks
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
It is a measure created by adding 18 multiple sclerosis (MS)-specific items to the Short Form 36 (SF-36), which contains 36 questions related to overall quality of life. Patients receive two separate scores, one for physical health and one for mental health. Higher scores indicate better outcomes. The scale's subparameters include physical health, physical role limitations, emotional role limitations, pain, energy levels, perceived health, social functions, cognitive functions, sexual functions, and overall quality of life. Total mental and physical scores are calculated based on the different coefficients of each sub-parameter.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed KILINÇ, Hacettepe University
- Investigators
- Muhammed KILINÇ, Prof. Dr., Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126730
- Sponsor's protocol ID
- FTREK25/78
- Status last verified
- Nov 2026
- First submitted
- 11 Aug 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of the EXOPULSE Mollii Suit on Spasticity and Functionality in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07126730
- Acronym / sponsor ID
- FTREK25/78
- Conditions
- Multiple Sclerosis
- Keywords
- spasticity, delete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity affects >80% of MS patients, with 35-54% experiencing moderate-to-severe symptoms, impairing mobility and sleep. Electrical stimulation parameters (e.g., high vs. low frequency) for spasticity management remain debated. The EXOPULSE Mollii Suit uses non-invasive, low-frequency stimulation to induce reciprocal inhibition and modulate spinal interneuron activity, potentially reducing spasticity. This study aims to compare EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone in improving spasticity and function in MS.
Detailed description
Spasticity is one of the most common symptoms in multiple sclerosis (MS) patients. Large-scale surveys indicate that over 80% of MS patients experience spasticity during their disease course, with 35-54% reporting moderate to severe spasticity. Spasticity, particularly in the lower extremities, is associated with stiffness, spasms, and pain and negatively affects walking, stair climbing, and sleep. While electrical stimulation is a potential treatment for spasticity, optimal stimulation parameters remain unclear. The most commonly used protocol involves high-frequency stimulation (~100 Hz), though some studies suggest low-frequency stimulation may also be effective.
The EXOPULSE Mollii suit (EXONEURAL NETWORK AB, Danderyd, Sweden) is a non-invasive, self-administered electrical stimulation system with integrated electrodes. It is designed to reduce spasticity and improve motor function in neurological disorders. The method is based on reciprocal inhibition, where low-frequency, low-intensity stimulation of antagonist muscles activates Ia inhibitory interneurons, reducing spasticity in agonist muscles. Additional mechanisms may include neuroplastic changes in spinal or brain circuits, similar to transcutaneous electrical nerve stimulation (TENS). This study aims to compare the effects of EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone on spasticity and functionality in MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXOPULSE Mollii + Exercise | Experimental | Device: EXOPULSE Mollii Suit + ExerciseDuring the 60-minute EXOPULSE Mollii stimulation session, patients will also perform a guided exercise program. |
| EXOPULSE Mollii | Active comparator | Device: EXOPULSE Mollii SuitFor 60 minutes, patients will only receive stimulation while wearing the EXOPULSE Mollii suit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with MS by a neurologist according to McDonald criteria
- Age >18 years
- EDSS score ≤6.5 (able to walk independently with or without assistive devices)
- Presence of spasticity
- Mini Mental State Examination (MMSE) score ≥24
Key exclusion criteria (4 listed)
- Received surgical intervention or botulinum toxin injection for spasticity within the last 6 months
- Presence of any neurological condition (other than MS) that may affect independent standing or walking
- Currently participating in another rehabilitation program
- Declined to participate or provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOPULSE Mollii Suit + ExerciseFirst, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Once patients put on the EXOPULSE Mollii Suit and the stimulation begins, they will undergo a personalized exercise program including strengthening, balance, and gait training with scheduled rest intervals. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks. | Device | EXOPULSE Mollii + Exercise |
| EXOPULSE Mollii SuitFirst, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Patients will wear the suit and receive stimulation while resting for 60 minutes. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks. | Device | EXOPULSE Mollii |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: 4 weeks
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.
Berg Balance Scale (BBS)
Time frame: 4 weeks
This 14-item scale is scored from 0 to 4 for each item. A score of 0 indicates inability to perform, while a score of 4 indicates normal performance. With a maximum total score of 56, higher scores indicate better balance ability.
OptoGait Gait Analysis System
Time frame: 4 weeks
During the test, the patient is asked to step onto the treadmill. They are then asked to adjust the treadmill speed to their preferred pace and walk for one minute. While walking on the treadmill, objective data related to their gait's time-distance characteristics is obtained. The evaluation takes five minutes.
10 secondary outcomes
EDSS (Expanded Disability Status Scale)
Time frame: 4 weeks
Visual Analog Scale (VAS) for pain and fatigue
Time frame: 4 weeks
Fatigue Severity Scale
Time frame: 4 weeks
9-Hole Peg Test
Time frame: 4 weeks
5 Times Sit to Stand Test
Time frame: 4 weeks
Timed Up and Go (TUG) Test
Time frame: 4 weeks
10 meter Walk Test
Time frame: 4 weeks
12-Item Multiple Sclerosis Walking Scale
Time frame: 4 weeks
Functional Independence Measure (FIM)
Time frame: 4 weeks
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed KILINÇ, Prof. Dr. principal investigator
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii Suit + Exercise and EXOPULSE Mollii Suit in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.