Brief Summary

Falls significantly reduce physical function as well as quality of life which leads to failure of successful aging among elders. There is a great need for automated assessing physical functions that can be address fall risks for those elderly living alone. The study aims to test validity and reliability of a depth camera-based physical function and fall risk assessment among healthy young and elderly adults with and without fall histories. The present study explores the concurrent, convergent, and discriminative validity of Azure Kinect-based physical function assessments, along with the intra-rater and inter-rater reliability of these measurements. The diagnostic accuracy and the optimal cut-off values of the Azure Kinect-based tests in differentiating fall risks will be provided. The enrolled participants will complete the following evaluations during a single session: Tandem Stance Test (TST), Five Times Sit to Stand Test (FTSS), Turn Up and Go Test (TUG), Berg Balance Scale (BBS), Functional Reach Test (FRT), Four Square Step Test (FSST), Grip Strength (GS), and Short Physical Performance Battery (SPPB). Each of the AK-based evaluation will be measured three times with simultaneous measurements of the same physical therapist directed tests: two trials will be measured by one physical therapist, while one trial will be measured by the another physical therapist.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

August 1, 2023

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed

17 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed

Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 8, 2024

Last Update Submit

July 19, 2024

Conditions

Fall Healthy Aging

Outcome Measures

Primary Outcomes (3)

AK-based Tandem Stance Test and Physical Therapist's Measurements of Tandem Stance Test
For the Tandem Stance Test comparisons, the Azure Kinect-based Tandem Stance Test system quantifies the distance traveled by the pelvic point in X, Y, and Z coordinates over a 30-second duration, while the physical therapist measures the time elapsed until the participant loses balance, with a maximum of 30 seconds. Participants remain in a tandem stance, positioning their preferred leg in front so that the heel of the front foot touches the toes of the back foot, ensuring both feet are aligned as straight as possible. They stand holding onto two chairs placed on their sides for stability and safety. Upon the cue to 'start', the participants let go of their hands, and both the system and the physical therapist's stopwatch initiate measurements. Participants try to maintain their stance for 30 seconds. Repositioning is noted when they step, use hands, or lose balance before 30 seconds. The total displacement (meters) and time until losing balance (seconds) are measured.
baseline
AK-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test
To assess Five Times Sit-to-Stand Test, a chair, 45cm in height and fixed to the ground, is placed three meters from the camera. Participants begin seated, and on start cue, repeatedly standd up and sit down five times. The Azure Kinect-based system automatically ends its measurement as the participant complete the fifth stand, whereas the physical therapist manually measures time using the stopwatch. The time measures in seconds from the system and therapist are compared.
baseline
AK-based Timed Up and Go Test and Physical Therapist's Measurements of Timed Up and Go Test
The Timed Up and Go test measures a person's mobility requiring both static and dynamic balance. Testing initiates with the participant moving from sit to stand and progresses through walking three meters within the laboratory, turning around, retracing steps, and returning to sit. The Azure Kinect-based system automatically stops timing the instant the participant sits, as does the physical therapist, who uses a stopwatch. The time to complete the tasks are measured in seconds.
baseline

Secondary Outcomes (5)

Short Physical Performance Battery
baseline
Berg Balance Scale
baseline
Functional Reach Test
baseline
Four-Square Step Test
baseline
Grip Strength
baseline

Study Arms (2)

Elders over 65-year-old

EXPERIMENTAL

* Those who are elders (≥65 years) * The enrolled participants completes the following evaluations during a single session: Tandem Stance Test (TST), Five Times Sit to Stand Test (FTSS), Turn Up and Go Test (TUG), Berg Balance Scale (BBS), Functional Reach Test (FRT), Four Square Step Test (FSST), Grip Strength (GS), and Short Physical Performance Battery (SPPB). The AK-based measurements are TST, FTSS, and TUG which are also the components of the SPPB.

Diagnostic Test: Azure Kinect-based Tandem Stance Test (ATST) and Physical Therapist's Measurements of Tandem Stance Test (PTST)Diagnostic Test: Azure Kinect-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test (PFTSS)Diagnostic Test: Azure Kinect-based Timed Up and Go Test (ATUG) and Physical Therapist's Measurements of Timed Up and Go Test (PTUG)Diagnostic Test: Short Physical Performance Battery (SPPB)Diagnostic Test: Berg Balance Scale (BBS)Diagnostic Test: Functional Reach Test (FRT)Diagnostic Test: Four-Square Step Test (FSST)Diagnostic Test: Grip Strength (GS)

Healthy adults under 65-year-old

ACTIVE COMPARATOR

* Those who are young adults over 18 and under 65 years old * The enrolled participants completes the following evaluations during a single session: Tandem Stance Test (TST), Five Times Sit to Stand Test (FTSS), Turn Up and Go Test (TUG), Berg Balance Scale (BBS), Functional Reach Test (FRT), Four Square Step Test (FSST), Grip Strength (GS), and Short Physical Performance Battery (SPPB). The AK-based measurements are TST, FTSS, and TUG which are also the components of the SPPB.

Interventions

Azure Kinect-based Tandem Stance Test (ATST) and Physical Therapist's Measurements of Tandem Stance Test (PTST)DIAGNOSTIC_TEST

For the Tandem Stance Test comparisons, the Azure Kinect-based Tandem Stance Test system quantified the distance traveled by the pelvic point to X, Y, and Z coordinates over a 30-second duration while the physical therapist measured the time elapsed until the participant lost balance was measured with a maximum of 30 seconds. Participants remained a tandem stance, positioning their preferred leg in front such that the heel of the front foot touched the toes of the back foot, ensuring both feet were aligned as straight as possible. They stood with holding on to two chairs each placed on their sides for stability and safety. Upon the cue to 'start', the participants let their hands go and both the Azure Kinect-based system and the physical therapist's stopwatch initiated their measurements. Participants tried to maintain their stance for 30 seconds. The participants had to reposition themselves when they stepped, used hands or lose balance for 30 seconds