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

NCT07781397 | Enrolling By Invitation

• 1 other identifier: PROTECT-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fall Risk; Fall Risk, Fall Prevention; Accidental Falls; Accidental Falls/Prevention & Control

Keywords

SuperPatch; LIBERTY; Haptic; Vibrotactile Trigger Technology; VTT; fall risk; fall prevention; accidental falls; balance; mobility; older adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of patch-associated sensations/side effects

  Throughout the 7-day study period, assessed at Day 7

Study Arms (2)

Active LIBERTY Patch (Vibrotactile/Haptic)

ACTIVE COMPARATOR

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

Control (Sham Patch)

SHAM COMPARATOR

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

Interventions

LIBERTY Patch DEVICE

A drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days.

Also known as: Haptic Vibrotactile Trigger Technology (VTT) Patch

Active LIBERTY Patch (Vibrotactile/Haptic)

Sham Patch DEVICE

A visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch.

Control (Sham Patch)

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• Clarity Science LLC: collaborator

Study Sites (1)

Anna Toker, MD

Mansfield, Texas, 76063, United States

Location

Related Publications (2)

• 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.

  PMID: 41057672 BACKGROUND

• 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.

  PMID: 2229948 BACKGROUND

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators are masked to patch assignment (active LIBERTY Patch vs. visually identical sham patch) throughout the 7-day study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two parallel groups. Participants in the Active group apply the LIBERTY Patch (embedded with Haptic Vibrotactile Trigger Technology) daily for 7 days, while participants in the Control group apply a visually identical sham patch daily for 7 days. Both groups complete a fall-risk/mobility assessment using the FallSkip wearable device and the Falls Efficacy Scale questionnaire at baseline and again at Day 7, allowing a between-group comparison of change in fall-risk classification and balance/mobility confidence. Neither participants nor investigators are informed of patch assignment during the 7-day comparison period. After Day 7, participants may optionally continue in the study using the alternate patch, outside the primary comparative endpoint.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: June 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)