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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT07132775
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Active full-body stimulation — DEVICE
    Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.
  • Sham full-body stimulation — OTHER
    Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Study Details

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.

Key Dates

Start date
Jul 23, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Berg Balance Scale [ Time Frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Sara Prokup
312-238-1355

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