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Recruiting NCT07132775

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

Conditions: Multiple Sclerosis, Fibromyalgia, Neurologic Disorder, Neuromuscular Disorders

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Shirley Ryan AbilityLab

Location: Shirley Ryan AbilityLab Chicago Illinois

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07132775). StuddyBuddy aggregates publicly available trial information.