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NCT Number: NCT07132775

Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain

The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fibromyalgia Immune System Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Disorder Neuromuscular Diseases Neuromuscular Disorders Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Sara Prokup

CONTACT

312-238-1355

About this study

Optimization Aim: Identify a systematic, methodological approach to device fitting, inclinic and at-home protocols using the Mollii suit, and optimization of collecting outcome measures at assessment visits. For example, up to 15 participants will complete a portion or all of the procedures listed in the "Procedures Involved" section of this protocol to determine an optimal approach.

Aim 1: Assess the safety of the Mollii suit during an in-clinic or at-home 12-week period consisting of daily sessions of a 60-minute duration in individuals with pain and/or spasticity from neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.

Aim 2: Evaluate the use of full-body active electrostimulation as compared to full-body sham electrostimulation as an intervention in-clinic or at-home for individuals experiencing pain and/or spasticity due to neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 75 years old
  • Medical clearance from physician
  • Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
  • For participants with a diagnosis of Multiple Sclerosis:
  • having a definite diagnosis for at least one month
  • Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) < 7).
  • Absence of relapses in the last three months
  • Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
  • Berg Balance Scale (BBS) score of < 46 (associated in the literature with a risk of fall)
  • For participants with a diagnosis of Fibromyalgia:

a. having a definite diagnosis for at least three months

  • Able to follow instructions and inform study staff of pain and/or discomfort
  • Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance

Exclusion criteria

  • Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
  • Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
  • No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
  • Pregnant and/or nursing

Treatment and study plan

Active full-body stimulation

Device

Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Sham full-body stimulation

Other

Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Primary outcomes

  1. Berg Balance Scale

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.

Secondary outcomes

  1. Manual Muscle Test

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A procedure to evaluate the strength of individual muscles relative to gravity and manual resistance. Scores can range from 0 (no contraction) to 5 (full contraction against max resistance)

  2. Modified Ashworth Scale

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    The Modified Ashworth Scale is used to grade the amount of hypertonicity / spasticity in individuals. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. Scores can range from 0 (no spasticity) to 4 (affected part rigid.)

  3. 10 Meter Walk Test

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    Participants are timed as they walk 10 meters at both their self-selected speed, and their fastest but safest speeds.

  4. 6 Minute Walk Test

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A test to measure the distance that a participant can walk over a period of 6 minutes.

  5. Timed Up and Go

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    The Timed Up and Go measures the time it takes for a person to stand up from a chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down.

  6. Twelve-Item Multiple Sclerosis Walking Scale

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A self-report questionnaire that measures the impact of multiple sclerosis on a person's walking ability. Scores range from 12 - 60, with higher scores indicating a greater impact on walking ability.

  7. Falls Efficacy Scale

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A questionnaire that measures a participant's fear of falling for items related to activities of daily living. Scores range from 10 - 100, with higher scores indicating an increased fear of falling.

  8. Multiple Sclerosis International Quality of Life Questionnaire

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A multi-dimensional questionnaire about a patient's quality of life for those who have multiple sclerosis.

  9. Clinical Global Impressions Scale

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

    A assessment of the clinician's view of a participant's global functioning prior to, and after initiating a study intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Arun Jayaraman, PhD

CONTACT

[email protected]

312-238-6875

Sara Prokup, DPT

CONTACT

312-238-1355

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Otto Bock Healthcare Products GmbH

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Sep 9, 2025

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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