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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Chicago

Shirley Ryan AbilityLab, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shirley Ryan AbilityLab,

Study Record Dates

2027-07