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

Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology (PROTECT)

This study evaluates whether a drug-free, non-invasive haptic patch (LIBERTY Patch) affects fall-risk classification and balance/mobility confidence in adults ages 55 to 85. Approximately 150 participants are assigned to wear either the active LIBERTY Patch or a visually identical sham patch daily for 7 days. Balance and mobility are assessed using the FallSkip wearable device and a Falls Efficacy Scale questionnaire at baseline and again after 7 days. Neither participants nor investigators know which patch is assigned during the study period, though this can be unblinded in an emergency.

The PROTECT Study is designed to classify participants into fall-risk categories and evaluate whether use of the LIBERTY Patch, a drug-free, non-invasive, investigational device employing Haptic Vibrotactile Trigger Technology, is associated with a change in fall-risk category or balance/mobility confidence relative to a sham (inactive) patch control.

After informed consent, participants complete a Baseline Survey (including the Falls Efficacy Scale, a 10-item instrument adapted from Tinetti et al., 1990, assessing confidence in performing daily activities without falling) and undergo a brief (2-3 minute) walking and mobility assessment using the FallSkip wearable device, worn at the waist, involving sitting, standing, walking several feet, and returning to a seated position. Participants are then given a study patch - either the active LIBERTY Patch or a visually identical sham patch - to wear daily. After 7 days, participants repeat the FallSkip mobility assessment and complete a Follow-Up Survey, which re-administers the Falls Efficacy Scale and adds items on patch satisfaction, ease of use, convenience, and any side effects experienced (hot/cold sensation, massage/tingling sensation, pressure sensation, or none). Neither the participant nor the investigator is informed of patch assignment during the study period, though the investigator can unblind in case of emergency. After the 7-day period, participants may optionally continue in the study using the alternate patch.

Inclusion Criteria:

• Ages 55 to 85, inclusive
• Able to provide written informed consent
• Able to walk independently or with assistive devices
• Lucid, with adequate cognitive ability to consent

Exclusion Criteria:

• History of severe neurological disorders (e.g., advanced Parkinson's, severe stroke history)
• Known allergies to adhesives
• Currently hospitalized
• Use of drugs of abuse (illicit or prescription)
• Severe visual/auditory impairments affecting gait or balance
• Terminal illness or life expectancy less than 6 months
• Severe dementia or cognitive impairment preventing consent
• Ongoing physical therapy specifically targeting balance/gait
• Post-stroke
• Pregnant
• Existing or planned implantation of a pacemaker or other electrical device