Fall RiskPROTECTNCT07781397
Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology
A study testing LIBERTY Patch in people with Fall Risk and Fall Risk, Fall Prevention, run by SuperPatch Limited LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Fall Risk, Fall Risk, Fall Prevention, Accidental Falls
- What is being tested?
- LIBERTY Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fall Risk, Fall Risk, Fall Prevention, Accidental Falls, Accidental Falls/Prevention & Control
- Being tested
- LIBERTY Patch, Sham Patch
- Keywords
- SuperPatch, LIBERTY, Haptic, Vibrotactile Trigger Technology, VTT, fall risk, fall prevention, accidental falls, balance, mobility, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIBERTY PatchDevice
Also called Haptic Vibrotactile Trigger Technology (VTT) Patch
A drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days.
Sham PatchDevice
A visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Day 7
Secondary outcomes (1)
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.
Measured: Throughout the 7-day study period, assessed at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start16 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuperPatch Limited LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781397
- Sponsor's protocol ID
- PROTECT-001
- Acronym
- PROTECT
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41057672Tinetti 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.
PubMed 2229948
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology (PROTECT)
- ClinicalTrials.gov ID
- NCT07781397
- Acronym / sponsor ID
- PROTECT / PROTECT-001
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SuperPatch Limited LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active LIBERTY Patch (Vibrotactile/Haptic) | Active comparator | Device: LIBERTY PatchParticipants 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. |
| Control (Sham Patch) | Sham comparator | Device: Sham PatchParticipants 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIBERTY PatchAlso: Haptic Vibrotactile Trigger Technology (VTT) PatchA drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days. | Device | Active LIBERTY Patch (Vibrotactile/Haptic) |
| Sham PatchA visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch. | Device | Control (Sham Patch) |
Primary outcome
Change in fall-risk/mobility assessment (FallSkip device)
Time frame: 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
Time frame: 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.
1 secondary outcome
Incidence of patch-associated sensations/side effects
Time frame: Throughout the 7-day study period, assessed at Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 41057672Fason 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.
- Background: PubMed 2229948Tinetti 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIBERTY Patch in people with Fall Risk and Fall Risk, Fall Prevention, run by SuperPatch Limited LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fall-risk/mobility assessment (FallSkip device) (time frame: Baseline and Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781397, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.