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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
NCT07132775 · Shirley Ryan AbilityLab
In plain English
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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.
Eligibility criteria
Inclusion Criteria:
1. Age 18 to 75 years old
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:
1. Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
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
Study design
Enrollment target: 15 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-07-23
Estimated completion: 2027-07
Last updated: 2025-09-09
Interventions
Device: Active full-body stimulationOther: Sham full-body stimulation
Primary outcomes
- • Berg Balance Scale (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)
Sponsor
Shirley Ryan AbilityLab · other
With: Otto Bock Healthcare Products GmbH
Contacts & investigators
ContactArun Jayaraman, PhD · contact · ajayaraman@sralab.org · 312-238-6875
ContactSara Prokup, DPT · contact · 312-238-1355
All locations (1)
Shirley Ryan AbilityLabRecruiting
Chicago, Illinois, United States