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| Name | Class |
|---|---|
| Accelera | UNKNOWN |
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This study assesses whether a small wearable ankle bracelet device can improve gait and mobility in the older adult. Before wearing the bracelet, participants will answer a brief questionnaire, have gait and mobility assessed via 3 CDC approved tests and an app, then wear the device and repeat these gait and mobility assessments, and complete a questionnaire.
This is a pilot, observational study with 20 volunteers at Jefferson's Ferry Independent Living. Before the Accelera ankle bracelets are applied, participants will complete a pre-study questionnaire. They will then complete 3 tests that the Centers for Disease Control (CDC) recommends for fall risk assessment, namely the chair stand test, 4-point balance test, and timed up and go test, while using their usual mobility assist devices. If the participants provide optional consent, they will undergo video-based gait/mobility analysis of information derived from the HIPAA compliant Onform video recording app, while they are using their usual mobility assistance devices, if any. In other words, a video recording is made with the app and stored on the apps' HIPAA compliant platform. With the faces obscured, measurements of their gait/mobility will be performed using additional programs as indicated in the Data section. After bracelet application, volunteers will then be encouraged to resume their normal ambulation' (while using their usual mobility assistive devices) for about 30 minutes at the study location as described below. The same 3 tests will be repeated after 30 minutes, along with a post-study questionnaire, and if they consented to video recording above, then repeat videorecording with the Onform video recording app would be performed. With the faces obscured, measurements of their gait/mobility will be performed using additional programs as indicated in the Data section. At this point, the ankle bracelets will be removed - with the subjects having worn them for about 1 hour total. There will be an additional up to 1 hour for completion of the pre- and post-study questionnaires, for a total study session duration of about 1.5 - 2 hours. At each session, we will apply these bracelets to a minimum of 1 patient per session. These sessions will occur at the Wellness Center/gym or other designated area at Jefferson's Ferry 1x per week, with a minimum of one patient for up to 8 patients/week if no holidays, until 20 patients have completed the study. To address infection control, a disposable sock will provide a physical barrier between the device and patient, while still allowing the patient to feel the stochastic resonance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing the Accelera device | Device | Wearing the Accelera device prior to retesting gait and mobility |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on mobility/gait assessments and subjective evaluation by participant | Performance on 3 CDC STEADI tests (timed up and go, chair stand, and 4 point balance test) and mobility as assessed by an optional app and subjective participant assessment on a questionnaire. | from enrollment to the end of the single study session for that participant |
| Measure | Description | Time Frame |
|---|---|---|
| sensory thresholds for the device | sensory threshold for the ankle bracelet device | while wearing the ankle bracelet device |
| Measure | Description | Time Frame |
|---|---|---|
| fall during the study session | falls that occur during the study session, while wearing and not wearing the device | during the single study session that the participant is enrolled in |
Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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Adults aged 65+ years who reside at Jefferson's Ferry independent living and generally use assistive devices for mobility, such as a cane or walker.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randeep Professor of Clinical Surgery | Contact | 631-444-8329 | randeep.jawa@stonybrookmedicine.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson's Ferry | South Setauket | New York | 11720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16287079 | Result | Priplata AA, Patritti BL, Niemi JB, Hughes R, Gravelle DC, Lipsitz LA, Veves A, Stein J, Bonato P, Collins JJ. Noise-enhanced balance control in patients with diabetes and patients with stroke. Ann Neurol. 2006 Jan;59(1):4-12. doi: 10.1002/ana.20670. | |
| 14550702 | Result | Priplata AA, Niemi JB, Harry JD, Lipsitz LA, Collins JJ. Vibrating insoles and balance control in elderly people. Lancet. 2003 Oct 4;362(9390):1123-4. doi: 10.1016/S0140-6736(03)14470-4. |
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to protect identity of participants
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol 10-5-25 | Oct 5, 2025 | Oct 22, 2025 | Prot_000.pdf |
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| 11833019 | Result | Liu W, Lipsitz LA, Montero-Odasso M, Bean J, Kerrigan DC, Collins JJ. Noise-enhanced vibrotactile sensitivity in older adults, patients with stroke, and patients with diabetic neuropathy. Arch Phys Med Rehabil. 2002 Feb;83(2):171-6. doi: 10.1053/apmr.2002.28025. |
| 19632845 | Result | Galica AM, Kang HG, Priplata AA, D'Andrea SE, Starobinets OV, Sorond FA, Cupples LA, Lipsitz LA. Subsensory vibrations to the feet reduce gait variability in elderly fallers. Gait Posture. 2009 Oct;30(3):383-7. doi: 10.1016/j.gaitpost.2009.07.005. Epub 2009 Jul 25. |
| 8893000 | Result | Collins JJ, Imhoff TT, Grigg P. Noise-enhanced tactile sensation. Nature. 1996 Oct 31;383(6603):770. doi: 10.1038/383770a0. No abstract available. |