Actively Recruiting
Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Neurological and Neuromuscular Conditions Causing Spasticity, Hyperreflexia, and Pain
Led by Shirley Ryan AbilityLab · Updated on 2025-09-09
15
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of the EXOPULSE Mollii suit, a full-body electrostimulation garment, for people with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and pain. The study focuses on individuals diagnosed with conditions such as Multiple Sclerosis or Fibromyalgia who experience these symptoms. The goal is to find out how well the suit works and how safe it is to use in these populations. Participants will be randomly assigned to wear the Mollii suit either with active electrical stimulation or sham (inactive) stimulation. They will wear the suit for 60 minutes every other day during a 12-week period, either in a clinic or at home. The study includes an optimization phase to improve device fitting and protocols, followed by assessments at specific intervals to measure the effects of the treatment. During the study, researchers will assess balance, muscle strength, spasticity, walking ability, and quality of life using various tests including the Berg Balance Scale and Multiple Sclerosis Walking Scale. These evaluations will occur before and after each treatment phase, around weeks 2, 4, and 6. Participants will be monitored for safety and ability to follow instructions, with the total study participation lasting approximately 12 weeks.
CONDITIONS
Brief 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 for at least one month
- For Multiple Sclerosis: ability to walk independently or with support (EDSS score less than 7)
- For Multiple Sclerosis: no relapses in the last three months
- For Multiple Sclerosis: spasticity score of at least 1+ on the Modified Ashworth Scale
- For Multiple Sclerosis: Berg Balance Scale score less than 46 indicating fall risk
- For Fibromyalgia: diagnosis for at least three months
- Able to follow instructions and report pain or discomfort
- Able to walk 10 meters with or without assistive devices or caregiver assistance
You will not qualify if you...
- Having implanted medical devices or equipment that can be affected by magnets (e.g., shunts)
- Swollen, infected, or inflamed skin areas where the suit will be worn
- No established somatic or neuropsychiatric diagnosis before joining the study
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants wear the full-body electrostimulation garment for 60 minutes every other day during two separate 2-week periods, receiving either active or sham stimulation in a randomized crossover design with a 2-week washout period between treatments.
Baseline and endpoint visits before and after each 2-week treatment period, plus visits during the 2-week washout period
Trial Site Locations
Total: 1 location
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Arun Jayaraman, PhD
S
Sara Prokup, DPT
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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