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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Accidental Falls; Accidental Falls/Prevention & Control; Fall Risk, Fall Prevention; Fall Risk
• Intervention / Treatment: Device: LIBERTY Patch; Device: Sham Patch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Mansfield, Texas, United States, 76063
      • Anna Toker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active LIBERTY Patch (Vibrotactile/Haptic); Participants apply the active LIBERTY Patch (Haptic Vibrotactile Trigger Technology) daily for 7 days, with fall-risk/mobility assessment (FallSkip device) and Falls Efficacy Scale survey completed at baseline and Day 7.	Device: LIBERTY Patch; A drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days.; Other Names: Haptic Vibrotactile Trigger Technology (VTT) Patch
Sham Comparator: Control (Sham Patch); Participants apply a visually identical sham patch without active technology daily for 7 days, with the same baseline and Day 7 assessments as the Active arm.	Device: Sham Patch; A visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fall-risk/mobility assessment (FallSkip device)	A 2-3 minute mobility assessment (sit-to-stand, walking, and return to seated position) using the FallSkip wearable device, comparing Active vs. Control groups.	Baseline and Day 7
Change in Falls Efficacy Scale score	A 10-item, self-reported scale (adapted from Tinetti et al., 1990) measuring confidence in performing daily activities (bathing, dressing, walking, transferring, etc.) without falling, scored 1 (very confident) to 10 (not confident at all) per item.	Baseline and Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patch-associated sensations/side effects	Self-reported occurrence of hot/cold sensation, massage/tingling sensation, pressure sensation, or none, associated with patch use.	Throughout the 7-day study period, assessed at Day 7

Collaborators and Investigators

• Sponsor: SuperPatch Limited LLC
• Collaborators: Clarity Science LLC

Publications and helpful links

General Publications

• Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
• Fason J, Hurwitz P, Gudin J. Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study. Pain Ther. 2025 Dec;14(6):1797-1807. doi: 10.1007/s40122-025-00780-0. Epub 2025 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: older adults; accidental falls; mobility; balance; fall risk; fall prevention; LIBERTY; Haptic; VTT; SuperPatch; Vibrotactile Trigger Technology
• Additional Relevant MeSH Terms: Equipment and Supplies; Transdermal Patch
• Other Study ID Numbers: PROTECT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. This is a minimal-additional-risk, single-site-network study in an at-risk elderly population (ages 55-85) evaluating an investigational, non-significant-risk device, conducted under a HIPAA Authorization and Advarra IRB oversight. Participant health data are used and disclosed only to the parties specified in the informed consent (the sponsor, Clarity Science, LLC, Advarra IRB, and applicable regulatory authorities) for purposes of conducting this study. Given the population's potential vulnerability (older adults, some with mobility impairment) and the narrow consented scope of data use, de-identified data sharing beyond these parties was not part of the consent framework, consistent with the study's HIPAA Authorization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No