Using Consumer-grade Wearable Devices for Fall Risk Evaluation and Alerts
NCT Number: NCT06508892
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mass Screening
Interventions: BEHAVIORAL: risk of fall
Sponsor: University of Michigan
Collaborators: University of Michigan-Flint
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-29
Completion Date: 2026-12-31
Locations: University of Michigan-Flint, Flint, Michigan, 48502, United States

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.

Primary Outcome Measures: 3D acceleration, Vertical, medial-lateral, and anterior-posterior acceleration, 60 seconds to 6 minutes|3D rotation, Vertical, medial-lateral, and anterior-posterior rotation, 60 seconds to 6 minutes
Secondary Outcome Measures: Montreal Cognitive Assessment (MoCA), Detect 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., 15 minutes|Berg Balance Scale (BBS), Assess 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., 15 minutes|Timed Up and Go (TUG), Assess 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., 5 minutes|Five Times Sit to Stand (5XSTS), Assess 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., 5 minutes|Activities-Specific Balance Confidence (ABC) Scale, Self-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., 10 minutes|6 Minute Walk Test (6MWT), Assess 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., 6 minutes