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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Arun Jayaraman, PhD
ajayaraman@sralab.org
312-238-6875
Backup
Sara Prokup, DPT
312-238-1355
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2027-07
Participants
Target number of participants: 15
Treatments
Experimental: Intervention
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.
Sham_comparator: Sham
Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: Otto Bock Healthcare Products GmbH

This content was sourced from clinicaltrials.gov