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
Recruiting · NCT07132775 · Interventional (participants receive a specific treatment) · Lead sponsor: Shirley Ryan AbilityLab
View the official record on ClinicalTrials.gov →Interventions studied
Active full-body stimulationSham full-body stimulation
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Shirley Ryan AbilityLab - Chicago, Illinois, United States