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Clinical Trials/NCT06508892
NCT06508892RecruitingNot Applicable

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

University of Michigan1 site in 1 country100 target enrollmentStarted: July 29, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
3D rotation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

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.

Intervention: risk of fall (Behavioral)

Outcomes

Primary Outcomes

3D rotation

Time Frame: 60 seconds to 6 minutes

Vertical, medial-lateral, and anterior-posterior rotation

3D acceleration

Time Frame: 60 seconds to 6 minutes

Vertical, medial-lateral, and anterior-posterior acceleration

Secondary Outcomes

  • Falls Efficacy Scale International(10 minutes)
  • Updated Perceived-Control Over Falling(5 minutes)
  • Fear of Falling Questionnaire Revised(10 minutes)
  • Timed Up and Go (TUG)(5 minutes)
  • Montreal Cognitive Assessment (MoCA)(15 minutes)
  • Berg Balance Scale (BBS)(15 minutes)
  • Five Times Sit to Stand (5XSTS)(5 minutes)
  • Activities-Specific Balance Confidence (ABC) Scale(10 minutes)
  • 6 Minute Walk Test (6MWT)(6 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal investigator
Principal Investigator

Jennifer Liao

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

University of Michigan

Study Sites (1)

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Identifiers

NCT ID
NCT06508892
Other Study IDs
U081219

Dates

First Submitted
(2 years ago)
First Posted
(2 years ago)
Primary Completion
(next year)
Study Completion
(next year)
Last Verified
(2 months ago)
Last updated
(last month)

Regulatory & Sharing

FDA Regulated Drug
No
FDA Regulated Device
No
IPD Sharing Plan
No
Has Results
No

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