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Using Consumer-grade Wearable Devices for Fall Risk Evaluation and Alerts

Using Consumer-grade Wearable Devices for Fall Risk Evaluation and Alerts

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06508892
Enrollment
100
Registered
2024-07-18
Start date
2024-07-29
Completion date
2027-12-31
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mass Screening

Keywords

fall risk

Brief summary

Creation and use of a smartphone application for older adults to assess the participants' risk of fall. Phase 1: Compare the accuracy and validity of accelerometer and gyroscopic data from a smartphone and gold-standard, wearable sensors gathered during balance and gait activities. Phase 2: Develop a model that integrates wearable sensor data and individual characteristics, such as age, medical conditions, exercises, previous falls, fear of falls, along with gait and balance outcome measurements, to evaluate fall risk in older adults. Phase 3: Integrate the computational model in the design of a mobile app for wearable devices for older adults to self-administer fall risk assessments and provide individualized risk of fall information.

Detailed description

Falls are prevalent among older adults and can cause serious problems. Falls in older adults can cause serious injuries that negatively impact their quality of life and can be life-threatening. Evaluating an individual's risk of fall is, typically, an important first step in preventing falls. Fall risk is commonly evaluated through clinical measurement scales, such as the Tinetti Performance Oriented Mobility Assessment (POMA) and Berg Balance Scale (BBS). Physical measurements using instruments, such as inertial measurement units (IMUs; accelerometers and gyroscopes) and force plates, can also be employed to evaluate an individual's fall risk. However, both clinical and instrumented measures are often only collected in clinical or research settings, thus making them less accessible to older adults and their care providers. Additionally, fall risk can only be evaluated infrequently, which can be a problem as health and environmental changes in the life of an older adult can necessitate more frequent measurement of fall risk. The research team proposes consumer-grade wearable devices (e.g. smartphones and watches) to fill the gap in current fall risk assessment. This approach has great potential as quick, simple, timely, and frequent measures of fall risk can help to reduce fall risk in older adults. The proposed research investigates older adults' gait and balance to identify potential links between wearable sensor measurements and fall risk. The types and granularity of data on physical activities that can be collected by consumer-grade wearable devices are more limited than using research-grade measurement. The investigators plan to use research-grade sensors to validate measures of gait and balance via consumer-grade wearable devices. Signal processing algorithms will be employed to extract the critical patterns from wearable device measurements that could be used for regular fall risk monitoring. A machine-learning computational model will also be developed to correlate the wearable data to clinical scales. This data will be used to design and build a mobile app for older adults to self-administer the fall risk test at home. The application design will be informed by factors such as one's physical environment, health condition, fear of falls, etc. and the goal is to develop an integrated system that offers fall risk assessment and provides alerts for older adults.

Interventions

BEHAVIORALrisk of fall

Gather information that will assist in determining risk of fall. The researchers will ask the subjects to perform several motor tests and study-related questionnaires.

Sponsors

University of Michigan
Lead SponsorOTHER
University of Michigan-Flint
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 65 years or older

Exclusion criteria

* have been diagnosed with neurological conditions such as multiple sclerosis, Parkinson's disease, traumatic brain injury, Alzheimer's disease, or have had a stroke in the last year * have orthopedic or cardiopulmonary conditions and/or surgeries in the past year * have physical limitations that would make it difficult or uncomfortable for individuals to perform the experimental tasks.

Design outcomes

Primary

MeasureTime frameDescription
3D acceleration60 seconds to 6 minutesVertical, medial-lateral, and anterior-posterior acceleration
3D rotation60 seconds to 6 minutesVertical, medial-lateral, and anterior-posterior rotation

Secondary

MeasureTime frameDescription
Montreal Cognitive Assessment (MoCA)15 minutesDetect cognitive involvement, Scores greater than 26 indicates normal cognition; scores less than 26 indicate cognitive impairment. Therefore, lower scores are a worse outcome. 18-25: Mild cognitive impairment; 10-17: Moderate cognitive impairment; Less than 10: Severe cognitive impairment.
Berg Balance Scale (BBS)15 minutesAssess static and dynamic balance and risk of fall. 14 item scale. Lower scores indicate poorer balance and higher scores indicate better balance. Score of less than 45 out of 56 indicates that the individual may be at a greater risk of fall. Out of 56, 41-56 Independent, 21-40 walking with assistance, 0-20 wheelchair bound.
Timed Up and Go (TUG)5 minutesAssess mobility, balance, walking ability and risk of fall. Less than or equal to 10 seconds: normal; 11-30 seconds: good mobility, can go outside alone, mobile without a gait assistive device; greater than 30 seconds: problems, cannot go outside alone, requires a gait assistive device.
Five Times Sit to Stand (5XSTS)5 minutesAssess functional lower extremity strength. The time it takes to complete the 5XSTS task is recorded. For community-dwelling older adults, the cut-off score is greater than or equal to 15 seconds which indicates risk of fall. Greater than or equal to 12 seconds identifies the need for further assessment for falls. Therefore, the greater the number of seconds, the greater the risk of fall.
Activities-Specific Balance Confidence (ABC) Scale10 minutesSelf-report measure of perceived balance confidence. 16 items are rated on a 0% to 100% whole number rating scale. Scores of zero represent no confidence; scores of 100 indicate complete confidence. Total the ratings (possible range = 0-1600) and divide by 16 (number of items) to get the patient's ABC score or overall percent of balance confidence. For older adults, scores less than 67% indicate risk for falling and accurately classify people who fall 84% of the time. Greater than 80% indicates a high level of physical functioning, 50-80% indicates moderate level of physical functioning, and less than 50% indicates low level of physical functioning.
6 Minute Walk Test (6MWT)6 minutesAssess distance walked over a duration of 6 minutes, submaximal test for endurance. For community-dwelling older adults: 60-69 years old: 572 (male) and 538 (female) meters; 70-79 years old: 527 (male) and 471 (female) meters, and 80-90 years old: 417 (male) and 392 (female) meters. Therefore, the less distance walked in 6 minutes indicates that the individual has less submaximal aerobic and functional walking capacity.
Falls Efficacy Scale International10 minutesFES-I is a modified measure that was introduced to improve the generalizability and the construct validity of the original. It is a measure of self efficacy which is commonly used to measure fear of falling. It gauges a person's perception of their ability to complete common activities without losing balance. It includes sixteen activities and the answer's possible lay on a scale of 1 (not at all concerned) to 4 (very concerned). Scores between 16-19 are low concern (i.e. high self efficacy), 20-27 have moderate concern, and 28-64 have high concern about falling.
Updated Perceived-Control Over Falling5 minutesUP-COF was developed to uncover maladaptive fear of falling. It identifies perceived control over balance threats as the bridging attribute between fear and increased fall risk. Thus it is able to distinguish between protective and maladaptive reactions to threats. It is composed of four statements that participants reply to 0 (strongly disagree) to 5 (strongly agree). Results of 13 or below indicate low perceived control.
Fear of Falling Questionnaire Revised10 minutesThe FFQ-R is a multi-item scale developed from the original Fear of Falling Questionnaire (FFQ) capable of uncovering fear of falling in community dwelling adults as well as in cases post hip injury. It assesses concepts related to FoF and has low correlation with depression and negative or positive affect. It is composed of 15 items self-report questionnaire with each item reported on a Likert scale of 1 (strongly disagree) - 4 (strongly agree). Higher scores indicate a higher degree of fear of falling.

Countries

United States

Contacts

CONTACTNathan Miller, Ph.D.
natmille@umich.edu810-762-3234
CONTACTCathy A Larson, PT, Ph.D.
clarson@umich.edu8107623373
PRINCIPAL_INVESTIGATORJennifer Liao, PT, Ph.D.

University of Michigan-Flint

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026