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
NCT ID: NCT07132775
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-07-23
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Intervention
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.
Active full-body stimulation
Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.
Sham
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.
Sham full-body stimulation
Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.
Interventions
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Active full-body stimulation
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
Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.
Eligibility Criteria
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Inclusion Criteria
2. Medical clearance from physician
3. Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
4. For participants with a diagnosis of Multiple Sclerosis:
1. having a definite diagnosis for at least one month
2. Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) \< 7).
3. Absence of relapses in the last three months
4. Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
5. Berg Balance Scale (BBS) score of \< 46 (associated in the literature with a risk of fall)
5. For participants with a diagnosis of Fibromyalgia:
a. having a definite diagnosis for at least three months
6. Able to follow instructions and inform study staff of pain and/or discomfort
7. Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance
Exclusion Criteria
2. Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
3. No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
4. Pregnant and/or nursing
18 Years
75 Years
ALL
No
Sponsors
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Otto Bock Healthcare Products GmbH
INDUSTRY
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Director - Max Nader Center for Rehabilitation Technologies and Outcomes Research
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Sara Prokup, DPT
Role: CONTACT
Facility Contacts
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Sara Prokup
Role: primary
Other Identifiers
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STU00221544
Identifier Type: -
Identifier Source: org_study_id
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