Fall InjuryCatchUNCT05544760
CatchU: A Quantitative Multisensory Falls-Assessment Study
A study testing CatchU Intervention in people with Fall Injury and Age Problem, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The ability to successfully integrate information across sensory systems is a vital aspect of functioning in the real world. To date, only a few studies have investigated the clinical translational value of multisensory integration processes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Injury, Age Problem, Well Aging
- What is being tested?
- CatchU Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
General inclusion criteria:
- Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
- Able to speak English at a level sufficient to undergo our assessment battery.
- Ambulatory. Participants are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit. These include participants who are bed-bound as a result of severe medical illness or those who require assistive medical devices (respiratory support or ventilators) that cannot be transported or those who cannot complete our mobility protocols. We will not exclude participants who use walking aids (canes, crutches) for ambulation. Participants who require walking aids to walk outside but are able to complete our mobility protocols without an assistive device or the assistance of another person will not be excluded.
General exclusion criteria (one or more criteria):
- Presence of dementia as defined as a score of ≥ 2 on the Alzheimer's Disease 8 (AD8) or < 25 on The Montreal Cognitive Assessment (MoCA). These cut scores and procedures have been validated in our and other aging studies.
- Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease. Individuals with recent cardiovascular or cerebrovascular event (Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass Graft, or stroke) will not be excluded if they meet above inclusion criteria. Many of these chronic conditions are very common in older adults. Hence, mere presence of these conditions will not be used to exclude participants if well controlled or of mild severity and if participants are able to complete training and mobility tasks.
- Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
- Any medical condition or chronic medication use (e.g., neuroleptics) in the judgment of the screening clinician that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
- Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
- Presence of clinical disorders that overtly alter attention like delirium.
- Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g., hip or knee replacement) and that prevent participants from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
- Severe auditory, visual, or somatosensory self-reported impairments. Visual acuity will be screened using a Snellen chart by the psychological assistant. Presence of neuropathy will be assessed using the Michigan Neuropathy Screening Instrument.
- Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols. Past history of these symptoms or presence of psychiatric illness not used as exclusion criteria.
- Living in nursing home.
- Participation in another intervention trial. Participants can participate in other observational studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
Official title: CatchU: A Quantitative Multisensory Falls-Assessment Randomized Clinical Trial
The ability to successfully integrate information across sensory systems is a vital aspect of functioning in the real world. To date, only a few studies have investigated the clinical translational value of multisensory integration processes. Previous work has linked the magnitude of visual-somatosensory integration (measured behaviorally using simple reaction time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes in healthy older adults. While multisensory integration effects have been measured across a wide array of populations using various sensory combinations and different neuroscience approaches, a gold standard for quantifying multisensory integration has been lacking. The investigator recently developed a step-by-step protocol for administering and calculating multisensory integration effects in an effort to facilitate innovative and novel translational research across diverse clinical populations and age-ranges. However, patients with severe medical conditions and/or mobility limitations often experience difficulty traveling to research facilities or joining time-demanding research protocols. Using the aforementioned protocol, the study team invented a mobile multisensory falls-assessment iPhone app called CatchU to facilitate physician discussion and counseling of falls in older adults during clinical visits (e.g., annual wellness visits with a subsequent telehealth call), in an attempt to alleviate disability, promote independence, and increase quality of life for older adults. The investigator team has provided a cross-sectional research proposal for a pilot study of 300 patients (over a 24-month period) in order to demonstrate acceptable-to-excellent predicative accuracy of CatchU for identifying older adults at-risk for falls.
- Conditions
- Fall Injury, Age Problem, Well Aging, Sensory Disorders
- Being tested
- CatchU Intervention
- Keywords
- falls, aging, multisensory integration
- Medical subject headings
- Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatchU InterventionOther
The CatchU Intervention arm will receive individualized recommendations (adapted from the CDC STEADI program) as outlined on the CatchU physician report sent to the participants physicians. These recommendations in combination with falls intervention referrals and falls counseling tips will be monitored and statistical investigation of the impact of CatchU intervention in preventing future falls will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. Meaning, older adults who are enrolled and screened with good integration abilities on the CatchU test (aka: VSI + (good) integrators), (VSI = visual-somatosensory integration) will not be placed in either the intervention or control group since better visual-somatosensory integration performance has been linked to better cognitive and motor outcomes. These participants will be included in examination of additional study aims not related to the intervention. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Control arm will be monitored every two months via telephone surveys to determine falls history, but will not receive the CatchU intervention. |
| CatchU Intervention | Experimental | Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance.
VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Intervention arm will be monitored every two months to determine falls history, but will also receive the CatchU intervention which consists of physicians relaying individualized recommendations from the CatchU physician report to the participant, as well as providing the participant with falls intervention referrals and falls counseling. Receives: Other: CatchU Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Falls
Information about falls (answers to questions regarding whether the participant has had a fall in the past 1 year or past 2 months after study enrollment) will be collected. If a fall is endorsed during the interview, further information regarding when and where the fall occurred and whether it led to a major injury or hospitalization will also be collected.
The relationship of multisensory integration performance on CatchU with history of falls in the past year (baseline) and incident falls over a 24-month period post-baseline visit (collected bimonthly through telephone interviews) will be assessed using Cox proportional hazard models. Here we will look at fall presence (yes or no) and time to fall (or censor if no fall) relative to baseline enrollment date
Measured: 24 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start13 Oct 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- This randomized clinical trial, first examines whether participants are good or bad multisensory integrators. If eligible and interested in participating, we will screen 300 participants level of multisensory integration. If participants are good integrators, no randomization will be necessary as these participants will not meet inclusion trial for the intervention trial. If participants are poor integrators, then they will be randomized into either the control (regular care) or intervention (CDC recommendations and falls counseling) arms. Note that be expect \~134 participants to be poor integrators. Those that are good integrators will not be included in the intervention trial but will be included in the larger observational study to test other study aims including 1) demonstrating acceptable concurrent validity of CatchU for identifying older adults' multisensory integration performance in older adults and 2) Examining predictive validity of CatchU in older adults.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Burke Rehabilitation Hospital, Montefiore Medical Center, Jet Worldwide Enterprises Incorporated
- Responsible party
- Sponsor
- Investigators
- Jeannette R Mahoney, PhD, Study chair, Albert Einstein College of MedicineMooyeon Oh-Park, MD, Principal investigator, The Burke Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544760
- Sponsor's protocol ID
- 2021-13418
- Acronym
- CatchU
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CatchU: A Quantitative Multisensory Falls-Assessment Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05544760
- Acronym / sponsor ID
- CatchU / 2021-13418
- Conditions
- Fall Injury, Age Problem, Well Aging, Sensory Disorders
- Keywords
- falls, aging, multisensory integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Burke Rehabilitation Hospital, Montefiore Medical Center, Jet Worldwide Enterprises Incorporated
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 16 Sep 2022 (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.
The ability to successfully integrate information across sensory systems is a vital aspect of functioning in the real world. To date, only a few studies have investigated the clinical translational value of multisensory integration processes. Previous work has linked the magnitude of visual-somatosensory integration (measured behaviorally using simple reaction time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes in healthy older adults. While multisensory integration effects have been measured across a wide array of populations using various sensory combinations and different neuroscience approaches, a gold standard for quantifying multisensory integration has been lacking. The investigator recently developed a step-by-step protocol for administering and calculating multisensory integration effects in an effort to facilitate innovative and novel translational research across diverse clinical populations and age-ranges. However, patients with severe medical conditions and/or mobility limitations often experience difficulty traveling to research facilities or joining time-demanding research protocols. Using the aforementioned protocol, the study team invented a mobile multisensory falls-assessment iPhone app called CatchU to facilitate physician discussion and counseling of falls in older adults during clinical visits (e.g., annual wellness visits with a subsequent telehealth call), in an attempt to alleviate disability, promote independence, and increase quality of life for older adults. The investigator team has provided a cross-sectional research proposal for a pilot study of 300 patients (over a 24-month period) in order to demonstrate acceptable-to-excellent predicative accuracy of CatchU for identifying older adults at-risk for falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized clinical trial, first examines whether participants are good or bad multisensory integrators. If eligible and interested in participating, we will screen 300 participants level of multisensory integration. If participants are good integrators, no randomization will be necessary as these participants will not meet inclusion trial for the intervention trial. If participants are poor integrators, then they will be randomized into either the control (regular care) or intervention (CDC recommendations and falls counseling) arms. Note that be expect ~134 participants to be poor integrators. Those that are good integrators will not be included in the intervention trial but will be included in the larger observational study to test other study aims including 1) demonstrating acceptable concurrent validity of CatchU for identifying older adults' multisensory integration performance in older adults and 2) Examining predictive validity of CatchU in older adults.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. Meaning, older adults who are enrolled and screened with good integration abilities on the CatchU test (aka: VSI + (good) integrators), (VSI = visual-somatosensory integration) will not be placed in either the intervention or control group since better visual-somatosensory integration performance has been linked to better cognitive and motor outcomes. These participants will be included in examination of additional study aims not related to the intervention. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Control arm will be monitored every two months via telephone surveys to determine falls history, but will not receive the CatchU intervention. |
| CatchU Intervention | Experimental | Other: CatchU InterventionPlacement into the intervention vs. control group is random, but dependent upon multisensory integration performance. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Intervention arm will be monitored every two months to determine falls history, but will also receive the CatchU intervention which consists of physicians relaying individualized recommendations from the CatchU physician report to the participant, as well as providing the participant with falls intervention referrals and falls counseling. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| CatchU InterventionThe CatchU Intervention arm will receive individualized recommendations (adapted from the CDC STEADI program) as outlined on the CatchU physician report sent to the participants physicians. These recommendations in combination with falls intervention referrals and falls counseling tips will be monitored and statistical investigation of the impact of CatchU intervention in preventing future falls will be determined. | Other | CatchU Intervention |
Primary outcome
Incident Falls
Time frame: 24 months following intervention
Information about falls (answers to questions regarding whether the participant has had a fall in the past 1 year or past 2 months after study enrollment) will be collected. If a fall is endorsed during the interview, further information regarding when and where the fall occurred and whether it led to a major injury or hospitalization will also be collected. The relationship of multisensory integration performance on CatchU with history of falls in the past year (baseline) and incident falls over a 24-month period post-baseline visit (collected bimonthly through telephone interviews) will be assessed using Cox proportional hazard models. Here we will look at fall presence (yes or no) and time to fall (or censor if no fall) relative to baseline enrollment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Catchu WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plans to share individual participant data.
Related trials for Fall Injury
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From Screening to Safety: Implementing the AL-STEADI Initiative in Assisted Living Communities
Fall, Fall Injury Prevention
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Vibratory Stimulation to Improve Balance Recovery
Fall, Fall Injury
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Virtual Reality for Walking and Balance in Older Adults
Accidental Falls, Gait Disorders
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SAFER Karachi - A Fall Prevention Intervention
Accidental Falls, Falls
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
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. This study is not recruiting at the moment.
Jeannette R Mahoney, PhD study chair
Albert Einstein College of Medicine
Mooyeon Oh-Park, MD principal investigator
The Burke Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CatchU Intervention in people with Fall Injury and Age Problem, run by Albert Einstein College of Medicine 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?
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: finished, as of the sponsor's last update on 27 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident Falls (time frame: 24 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.