Older Adults Who Use an Assistive Device for MobilityNCT07220707
Wearable Technology to Assist Gait and Mobility in the Older Adult
An observational study of Older Adults Who Use an Assistive Device for Mobility, run by Stony Brook University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults Who Use an Assistive Device for Mobility
- What is being tested?
- Wearing the Accelera device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Dec 2028
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 65+ years old residing at Independent Living at Jefferson's Ferry
- Express interest in the ankle wearable device
- Have capacity as measured by being alert and oriented to person, place, and time
- Can communicate in English and provide written consent
- Able to walk and stand unsupported by others and feel ankle vibrations at maximum amplitude.
- Answers "Yes" to at least one: worry about falling, had a fall within last year, feel unsteady when walking, enrolled in a fall prevention program, or use/have used assistive devices, such as canes or walkers
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Diagnosed with neurodegenerative diseases (such as Parkinson's, Alzheimer's, or Amyotrophic Lateral Sclerosis (ALS))
- Disability from a stroke or other major neurologic disorder resulting in leg paralysis
- Active ulcers/rashes/infections on feet or legs, or using orthotics other than arch supports or over the counter knee/ankle supports
- Significant lymphedema/peripheral edema/or large ankle size that prevents ankle wearable device application or functionality
- Cannot give written consent
Show all 12Show fewer
- Unable to walk today or generally use wheelchairs
- Unable to participate due to medical or cognitive reasons
- Any lower extremity amputation other than one toe
- On anticoagulants or antiplatelet agents other than aspirin
- Unable to participate due to other medical or cognitive reasons
- Age under 65 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Jefferson's Ferry
South Setauket, New York, 11720
Randeep Jawa, MD, 631-444-8329, randeep.jawa@stonybrookmedicine.edu
About this study
Official title: A Pilot Study to Assess the Role of Accelera Stochastic Resonance Wearable Technology to Assist Gait and Mobility in the Older Adult
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.
Read the detailed description
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.
- Being tested
- Wearing the Accelera device
- Keywords
- older adult, assistive device, stochastic resonance, mobility, gait, fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing the Accelera deviceDevice
Wearing the Accelera device prior to retesting gait and mobility
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the end of the single study session for that participant
Secondary outcomes (1)
sensory thresholds for the device
sensory threshold for the ankle bracelet device
Measured: while wearing the ankle bracelet device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Older Adults Who Use an Assistive Device for MobilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Accelera
- Responsible party
- Principal investigator, Randeep Jawa, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220707
- Sponsor's protocol ID
- 2025-00142
- Other IDs
- 2025
- Status last verified
- Oct 2025
- First submitted
- 20 Oct 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to protect identity of participants
Publications
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.
PubMed 16287079Priplata 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.
PubMed 14550702Liu 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.
PubMed 11833019Galica 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.
PubMed 19632845Collins JJ, Imhoff TT, Grigg P. Noise-enhanced tactile sensation. Nature. 1996 Oct 31;383(6603):770. doi: 10.1038/383770a0. No abstract available.
PubMed 8893000
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Role of Accelera Stochastic Resonance Wearable Technology to Assist Gait and Mobility in the Older Adult
- ClinicalTrials.gov ID
- NCT07220707
- Acronym / sponsor ID
- 2025-00142
- Keywords
- older adult, assistive device, stochastic resonance, mobility, gait, fall
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Accelera
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Oct 2025 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 65+ years old residing at Independent Living at Jefferson's Ferry
- Express interest in the ankle wearable device
- Have capacity as measured by being alert and oriented to person, place, and time
- Can communicate in English and provide written consent
- Able to walk and stand unsupported by others and feel ankle vibrations at maximum amplitude.
Key exclusion criteria (12 listed)
- Diagnosed with neurodegenerative diseases (such as Parkinson's, Alzheimer's, or Amyotrophic Lateral Sclerosis (ALS))
- Disability from a stroke or other major neurologic disorder resulting in leg paralysis
- Active ulcers/rashes/infections on feet or legs, or using orthotics other than arch supports or over the counter knee/ankle supports
- Significant lymphedema/peripheral edema/or large ankle size that prevents ankle wearable device application or functionality
- Cannot give written consent
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 |
|---|---|---|
| Wearing the Accelera deviceWearing the Accelera device prior to retesting gait and mobility | Device | – |
Primary outcome
Performance on mobility/gait assessments and subjective evaluation by participant
Time frame: from enrollment to the end of the single study session for that 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.
1 secondary outcome
sensory thresholds for the device
Time frame: while wearing the ankle bracelet device
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 Oct 2025.
- Results publication: PubMed 16287079Priplata 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.
- Results publication: PubMed 14550702Priplata 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.
- Results publication: PubMed 11833019Liu 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.
- Results publication: PubMed 19632845Galica 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.
- Results publication: PubMed 8893000Collins JJ, Imhoff TT, Grigg P. Noise-enhanced tactile sensation. Nature. 1996 Oct 31;383(6603):770. doi: 10.1038/383770a0. No abstract available.
- Individual participant dataSharing planned: Undecided. to protect identity of participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults Who Use an Assistive Device for Mobility, run by Stony Brook University 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Oct 2025. 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. 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?
Contact Randeep Professor of Clinical Surgery (631-444-8329, randeep.jawa@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on mobility/gait assessments and subjective evaluation by participant (time frame: from enrollment to the end of the single study session for that participant). 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 NCT07220707, which also lists 5 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 Oct 2025.