About this trial
This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent prior to any study procedure.
Adults ≥18 years.
Clinical diagnosis of peripheral neuropathy.
Willingness and ability to attend weekly sessions, perform home use, and return for follow-up.
Disqualifiers
Age < 18 years at the time of consent.
Active foot ulcer, infection, or severe dermatological condition at electrode contact sites.
Cognitive impairment that precludes informed consent or device use.
Implanted electrical devices or pacemakers.
Trial design
Parallel
Treatments tested in this trial
Active wearable device
DeviceA non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
Sham wearable device
DeviceA sham version of the wearable device without active functionality.
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in Functional Gait Assessment (FGA) Total Score
Change in Functional Gait Assessment (FGA) total score (0-30 points) from baseline to 2 months. Higher scores indicate better gait and balance performance.
Locations
This trial is not recruiting at the moment. You can still explore other options: