Fall Risk, Fall Risk, Fall Prevention, Accidental Falls, Accidental Falls/Prevention & Control
Conditions
Keywords
SuperPatch, LIBERTY, Haptic, Vibrotactile Trigger Technology, VTT, fall risk, fall prevention, accidental falls, balance, mobility, older adults
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.
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.
Interventions
DEVICELIBERTY Patch
A drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days.
DEVICESham Patch
A visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch.
Sponsors
SuperPatch Limited LLC
Clarity Science LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators are masked to patch assignment (active LIBERTY Patch vs. visually identical sham patch) throughout the 7-day study period.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of patch-associated sensations/side effects | Throughout the 7-day study period, assessed at Day 7 | Self-reported occurrence of hot/cold sensation, massage/tingling sensation, pressure sensation, or none, associated with patch use. |
Countries
United States
Outcome results
None listed