Effects of EXOPULSE Mollii Suit on Spasticity and Functionality in Multiple Sclerosis Patients

Browse trials for

• Multiple Sclerosis 3,460
• Muscle Spasticity 704

Keywords

• spasticity
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Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Study arms

• Experimental
  EXOPULSE Mollii + Exercise

  During the 60-minute EXOPULSE Mollii stimulation session, patients will also perform a guided exercise program.

  Device: EXOPULSE Mollii Suit + Exercise

• Active comparator
  EXOPULSE Mollii

  For 60 minutes, patients will only receive stimulation while wearing the EXOPULSE Mollii suit.

  Device: EXOPULSE Mollii Suit

Interventions

• DeviceEXOPULSE Mollii Suit + Exercise

  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.

• DeviceEXOPULSE Mollii Suit

  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.

Primary outcomes

1. 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.

   Time frame: 4 weeks

2. 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.

   Time frame: 4 weeks

3. 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.

   Time frame: 4 weeks

Secondary outcomes

1. 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.

   Time frame: 4 weeks

2. 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.

   Time frame: 4 weeks

3. 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.

   Time frame: 4 weeks

4. 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.

   Time frame: 4 weeks

5. 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.

   Time frame: 4 weeks

6. 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.

   Time frame: 4 weeks

7. 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.

   Time frame: 4 weeks

8. 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.

   Time frame: 4 weeks

9. 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.

   Time frame: 4 weeks

10. 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.

    Time frame: 4 weeks

Individual participant data

Plan to share: No