Study of the EXOPULSE Mollii Suit for Spasticity, Hyperreflexia, and Pain
This study is evaluating the safety and effectiveness of the EXOPULSE Mollii suit, a full-body electrostimulation garment, for individuals experiencing spasticity (muscle stiffness), hyperreflexia (overactive reflexes), and pain due to neurological or neuromuscular conditions like Multiple Sclerosis or Fibromyalgia. Participants will wear the suit, which delivers a low-grade electrical stimulation to muscle groups. The study aims to see if the active stimulation helps improve balance compared to a sham (inactive) stimulation. We are looking for up to 15 participants, aged 18 to 75, who meet specific medical criteria. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll up to 15 participants. It compares active full-body electrostimulation to sham full-body electrostimulation.
- What's involved
- Participants will complete procedures over approximately 6 weeks, including wearing the Mollii suit for daily 60-minute sessions and having balance measured at several time points.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for approximately 6 weeks, with measurements taken after 2 weeks of each intervention arm.
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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
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Berg Balance ScaleBaseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks
The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.