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.
Signed informed consent prior to any study procedure
Adults ≥ 18 years
Clinical diagnosis of peripheral neuropathy, confirmed per site procedures and neurophysiological testing (e.g. NCV)
Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance < 30 seconds
Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins)
Untreated/unhealed fractures in the foot and ankle
Cancerous growth in the planned treatment area
Severe peripheral vascular disease (e.g., gangrene)
Parallel
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.
Functional Gait Assessment (FGA) total score
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks.
Functional Gait Assessment (FGA) total score
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks. To gain additional knowledge on whether there are changes between supervised and home-use phase
Timed-up and Go (TUG) in seconds
The Timed Up and Go (TUG) test assesses functional mobility. Participants are instructed to stand up from a chair, walk 3 metres at their usual pace, turn around, walk back to the chair, and sit down. The time from the command to start until the participant is seated again is recorded in seconds. A shorter time indicates better functional mobility.
Neuropathic pain symptoms (NPSI questionnaire)
Captures changes in neuropathic pain intensity and quality.
Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire)
Evaluates impact of intervention on daily function and well-being.
Exploratory - Sensory function - Temperature measurement using the thermal imaging camera
Temperature distribution in the feet)
Safety Outcome
All Adverse events (AEs): incidence, severity, seriousness, relatedness to device/procedures
Safety Outcome
All Device deficiencies: number, type, corrective actions
