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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShirley Ryan AbilityLab

About this trial

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

Qualifiers

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

having a definite diagnosis for at least one month

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Active full-body stimulation
  • Sham full-body stimulation

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shirley Ryan AbilityLab

Lead sponsor

Otto Bock Healthcare Products GmbH

Collaborator