Prevention and Reduction of Falls: testing and Evaluating Cutting Edge Haptic Technology

The PROTECT Study is designed to classify participants into fall‐risk categories andevaluate whether use of the LIBERTY Patch, a drug‐free, non‐invasive, investigationaldevice employing Haptic Vibrotactile Trigger Technology, is associated with a change infall‐risk category or balance/mobility confidence relative to a sham (inactive) patchcontrol.After informed consent, participants complete a Baseline Survey (including the FallsEfficacy Scale, a 10‐item instrument adapted from Tinetti et al., 1990, assessingconfidence in performing daily activities without falling) and undergo a brief (2‐3minute) walking and mobility assessment using the FallSkip wearable device, worn at thewaist, involving sitting, standing, walking several feet, and returning to a seatedposition. Participants are then given a study patch ‐ either the active LIBERTY Patch ora visually identical sham patch ‐ to wear daily. After 7 days, participants repeat theFallSkip mobility assessment and complete a Follow‐Up Survey, which re‐administers theFalls Efficacy Scale and adds items on patch satisfaction, ease of use, convenience, andany side effects experienced (hot/cold sensation, massage/tingling sensation, pressuresensation, or none). Neither the participant nor the investigator is informed of patchassignment during the study period, though the investigator can unblind in case ofemergency. After the 7‐day period, participants may optionally continue in the studyusing the alternate patch.