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

NCT ID: NCT06508892

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-29

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Mass Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Comparison of acceleration and 3D rotation during balance and movement

Can consumer-grade sensors used in mobile phones provide an accurate and valid measure of balance and gait when compared to gold standard research-grade sensors? A computational model for risk of fall will be developed.

risk of fall

Intervention Type BEHAVIORAL

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.

Interventions

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risk 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan-Flint

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Liao

Assistant Professor of Physical Therapy, College of Health Sciences, The University of Michigan-Flint and Adjunct Assistant Professor of Radiology, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Liao, PT, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan-Flint

Locations

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University of Michigan-Flint

Flint, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nathan Miller, Ph.D.

Role: CONTACT

810-762-3234

Cathy A Larson, PT, Ph.D.

Role: CONTACT

8107623373

Facility Contacts

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Nathan Miller, Ph.D.

Role: primary

810-762-3234

Cathy A Larson, Ph.D.

Role: backup

8107623373

References

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Chen M, Wang H, Yu L, Yeung EHK, Luo J, Tsui KL, Zhao Y. A Systematic Review of Wearable Sensor-Based Technologies for Fall Risk Assessment in Older Adults. Sensors (Basel). 2022 Sep 7;22(18):6752. doi: 10.3390/s22186752.

Reference Type BACKGROUND
PMID: 36146103 (View on PubMed)

Hsieh KL, Roach KL, Wajda DA, Sosnoff JJ. Smartphone technology can measure postural stability and discriminate fall risk in older adults. Gait Posture. 2019 Jan;67:160-165. doi: 10.1016/j.gaitpost.2018.10.005. Epub 2018 Oct 9.

Reference Type BACKGROUND
PMID: 30340129 (View on PubMed)

Related Links

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https://ieeexplore.ieee.org/document/9147170

New Approach for Fall Detection System Using Embedded Technology

Other Identifiers

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U081219

Identifier Type: -

Identifier Source: org_study_id

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