Actively Recruiting
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
Led by Shirley Ryan AbilityLab · Updated on 2025-09-09
15
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
S
Shirley Ryan AbilityLab
Lead Sponsor
O
Otto Bock Healthcare Products GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Medical clearance from a physician
- Experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions, or have a diagnosis of Multiple Sclerosis or Fibromyalgia
- For Multiple Sclerosis diagnosis: diagnosis for at least one month
- For Multiple Sclerosis diagnosis: ability to walk independently or with support (EDSS score < 7)
- For Multiple Sclerosis diagnosis: no relapses in the last three months
- For Multiple Sclerosis diagnosis: spasticity score of at least 1+ on the Modified Ashworth Scale
- For Multiple Sclerosis diagnosis: Berg Balance Scale score below 46
- For Fibromyalgia diagnosis: diagnosis for at least three months
- Able to follow instructions and report pain or discomfort
- Able to walk 10 meters without body weight support with or without assistive devices or caregiver assistance
You will not qualify if you...
- Have implanted medical devices that can be disrupted by magnets (e.g., shunts)
- Have swollen, infected, or inflamed skin areas where the suit will be used
- Do not have an established somatic or neuropsychiatric diagnosis before joining the study
- Are pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Arun Jayaraman, PhD
CONTACT
S
Sara Prokup, DPT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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