Health TrialsbyHealthPanel

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

ConditionMass Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

65 years or older

Disqualifiers

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.

Trial population

older adults ages 65 years and older

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • risk of fall

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Comparison of acceleration and 3D rotation during balance and movement1 intervention

Trial outcomes

Primary outcomes

1

3D acceleration

Vertical, medial-lateral, and anterior-posterior acceleration

Time frame
60 seconds to 6 minutes
2

3D rotation

Vertical, medial-lateral, and anterior-posterior rotation

Time frame
60 seconds to 6 minutes

Secondary outcomes

1

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.

Time frame
15 minutes
2

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.

Time frame
15 minutes
3

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.

Time frame
5 minutes
4

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.

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

University of Michigan-Flint

Collaborator

Source ClinicalTrials.gov
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