Evaluation of the Leia Sensory Prosthesis Wearable Device to Improve Balance and Walking in Adults with Peripheral Neuropathy

What this Trial Is About

Researchers are evaluating a wearable device designed to support balance and walking in adults with peripheral neuropathy. This trial aims to assess whether the device can improve gait stability and balance during daily activities while also examining its safety, comfort, and overall user acceptability. The study compares an active device with a sham inactive version in a controlled, randomized setting. Participants will be randomly assigned to use either the active wearable device or a sham device that lacks active functionality. They will use the device over a defined period to evaluate changes in gait and balance. The study includes weekly sessions and a home-use phase to monitor device performance and user experience. Both groups will be observed and assessed throughout the study to compare outcomes. Participants will attend weekly visits and perform home use of the device, with follow-up assessments up to 80 days. Researchers will measure changes in the Functional Gait Assessment score, timed-up-and-go test, neuropathic pain symptoms, quality of life, sensory function tests, fall risk, neuroimaging in some participants, and objective gait parameters like step length and heel-strike force. Treatment compliance and device usability will also be monitored to evaluate safety and effectiveness over the study period.

Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy