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

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Conditions

Multiple SclerosisFibromyalgiaNeurologic DisorderNeuromuscular Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2025-07-23
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07132775

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 to 75 years old
  2. 2. Medical clearance from physician
  3. 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. 4. For participants with a diagnosis of Multiple Sclerosis:
  5. 1. having a definite diagnosis for at least one month
  6. 2. Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) \< 7).
  7. 3. Absence of relapses in the last three months
  8. 4. Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
  9. 5. Berg Balance Scale (BBS) score of \< 46 (associated in the literature with a risk of fall)
  10. 5. For participants with a diagnosis of Fibromyalgia:
  11. 6. Able to follow instructions and inform study staff of pain and/or discomfort
  12. 7. Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance
  1. 1. Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
  2. 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. 3. No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
  4. 4. Pregnant and/or nursing

Contacts and Locations

Study Contact

Arun Jayaraman, PhD
CONTACT
312-238-6875
ajayaraman@sralab.org
Sara Prokup, DPT
CONTACT
312-238-1355

Study Locations (Sites)

Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-23
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-23
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Fibromyalgia
  • Neurologic Disorder
  • Neuromuscular Disorders