Brief 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. 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.
Brief Title
CatchU: A Quantitative Multisensory Falls-Assessment Study
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Fall Injury
Age Problem
Well Aging
Sensory Disorders
Eligibility Criteria
General inclusion criteria:
1. Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
2. Able to speak English at a level sufficient to undergo our assessment battery.
3. 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):
1. 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.
2. 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.
3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
4. 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.
5. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
6. Presence of clinical disorders that overtly alter attention like delirium.
7. 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.
8. 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.
9. 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.
10. Living in nursing home.
11. Participation in another intervention trial. Participants can participate in other observational studies.
1. Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
2. Able to speak English at a level sufficient to undergo our assessment battery.
3. 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):
1. 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.
2. 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.
3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
4. 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.
5. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
6. Presence of clinical disorders that overtly alter attention like delirium.
7. 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.
8. 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.
9. 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.
10. Living in nursing home.
11. Participation in another intervention trial. Participants can participate in other observational studies.
Inclusion Criteria
inclusion criteria:
1. Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
2. Able to speak English at a level sufficient to undergo our assessment battery.
3. 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.
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.
3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
4. 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.
5. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
6. Presence of clinical disorders that overtly alter attention like delirium.
7. 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.
8. 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.
9. 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
1. Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
2. Able to speak English at a level sufficient to undergo our assessment battery.
3. 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.
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.
3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
4. 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.
5. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
6. Presence of clinical disorders that overtly alter attention like delirium.
7. 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.
8. 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.
9. 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
Gender
All
Gender Based
false
Keywords
falls
aging
multisensory integration
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT05544760
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2021-13418
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
CatchU: A Quantitative Multisensory Falls-Assessment Randomized Clinical Trial
Primary Outcomes
Outcome Description
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
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
Outcome Measure
Falls
Outcome Time Frame
24 months
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mooyeon Oh-Park
Investigator Email
ohpark@montefiore.org
Investigator Department
Neurology
Study Department
Rehabilitation Medicine
Study Division
Please Specify
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
MeSH Terms
SENSATION DISORDERS
NEUROLOGIC MANIFESTATIONS
NERVOUS SYSTEM DISEASES
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS