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Enrolling by invitation Not applicable

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

NCT07781397 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2025-06-16
Last updated
2026-08-24

Condition(s) studied

Fall RiskFall Risk, Fall PreventionAccidental FallsAccidental Falls/Prevention & Control

Investigational drug(s) / intervention(s)

LIBERTY PatchSham Patch

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

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

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in fall-risk/mobility assessment (FallSkip device) — Baseline and Day 7
    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.
  • Change in Falls Efficacy Scale score — Baseline and Day 7
    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.

Trial sites (1)

FacilityCityRegionStatus
Anna Toker, MD Mansfield Texas
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07781397 on ClinicalTrials.gov ↗ ← All trials in the USA