Validity and Reliability of a Depth Camera-based Automated Physical Function and Fall Risk Assessments

Not Applicable

Completed

• Conditions: Fall; Healthy Aging
• Interventions: 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)

• Registration Number: NCT06519864
• Lead Sponsor: Sahmyook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2023-10-22
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• those who: (1) are adults (≥18 years); (2) are able to follow instructions during physical examinations; (3) can walk independently for at least six meters; and (4) agrees to participate and provide written consent.

Exclusion Criteria

• those who have: (1) orthopedic injuries; (2) neurological disease; (3) pain or inflammation; (4) visual or hearing problems; (5) a previous history of surgery; (6) serious medical concerns; or (7) refuses to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy adults under 65-year-old	Grip Strength (GS)	* 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.
Healthy adults under 65-year-old	Azure Kinect-based Timed Up and Go Test (ATUG) and Physical Therapist's Measurements of Timed Up and Go Test (PTUG)	* 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.
Elders over 65-year-old	Azure Kinect-based Tandem Stance Test (ATST) and Physical Therapist's Measurements of Tandem Stance Test (PTST)	* 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.
Elders over 65-year-old	Azure Kinect-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test (PFTSS)	* 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.
Healthy adults under 65-year-old	Azure Kinect-based Tandem Stance Test (ATST) and Physical Therapist's Measurements of Tandem Stance Test (PTST)	* 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.
Healthy adults under 65-year-old	Short Physical Performance Battery (SPPB)	* 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.
Elders over 65-year-old	Azure Kinect-based Timed Up and Go Test (ATUG) and Physical Therapist's Measurements of Timed Up and Go Test (PTUG)	* 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.
Elders over 65-year-old	Short Physical Performance Battery (SPPB)	* 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.
Elders over 65-year-old	Functional Reach Test (FRT)	* 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.
Elders over 65-year-old	Four-Square Step Test (FSST)	* 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.
Elders over 65-year-old	Grip Strength (GS)	* 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.
Elders over 65-year-old	Berg Balance Scale (BBS)	* 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.
Healthy adults under 65-year-old	Azure Kinect-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test (PFTSS)	* 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.
Healthy adults under 65-year-old	Functional Reach Test (FRT)	* 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.
Healthy adults under 65-year-old	Berg Balance Scale (BBS)	* 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.
Healthy adults under 65-year-old	Four-Square Step Test (FSST)	* 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.

Primary Outcome Measures

Name	Time	Method
AK-based Timed Up and Go Test and Physical Therapist's Measurements of Timed Up and Go Test	baseline	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.
AK-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test	baseline	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.
AK-based Tandem Stance Test and Physical Therapist's Measurements of Tandem Stance Test	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	baseline	Participants are scored from 0-4 for each task, where a score of 0 indicates an inability to perform the task, while 4 denotes independence in execution. The maximal total score is 56, indicating that an individual has perfect balance. Administering the Berg Balance Scale is efficient, taking between 10 to 20 minutes, and requires only basic equipment such as a chair, a stopwatch, a ruler, and a step within a small space. The score in points are measured after completion of all tasks in the Berg Balance Scale.
Short Physical Performance Battery	baseline	Short Physical Performance Battery is comprised of three tests: a Timed Up and Go test where the respondent walks a distance of 3 meters at their comfortable pace, a Five Times Sit to Stand test that also measures duration, and a standing balance test which determines a respondent's capacity to maintain three different stances of side-by-side, semi-tandem, and full tandem, each for 10 seconds.; The time to complete each task are measured in seconds
Functional Reach Test	baseline	Participants, standing without shoes on, place their side in a line with the wall so that there is no contact. Their stance is symmetrical with feet comfortably spaced. Their shoulders are flexed at a 90° angle to the wall, elbows remain extended, and fists are clenched. The zero point is established at the touch point of the third metacarpal on a horizontally mounted measuring tape, level with the floor. The tape is aligned with each participant's acromion height. Participants are then directed to reach forward maximally without taking a step, lifting their heels, or losing balance. The reach distance is measured as the difference between the initial and final third metacarpal positions on the tape. The distances of the reach are measured in meters.
Grip Strength	baseline	The maximal grip force strength of the dominant hand, representative of muscle strength in the upper extremity, is measured with a digital isometric hand dynamometer (Electronic hand dynamometer, PRO-SPECS®, Seoul, South Korea). The participant holds the shoulder adducted with the elbow flexed at 90° while keeping the forearm in a neutral position. The average from three attempts at squeezing is used for analysis. The grip strength are measured in weight (kilograms)
Four-Square Step Test	baseline	The subjects are instructed to step over four pieces of straight tape (90 cm long) arranged in a cross on the ground. The subjects step forward into the next quadrants, then to their right into the next quadrant, then backward to the last quadrant, and finally leftward into the starting quadrant, proceeding in a clockwise sequence. This pattern is then retraced in reverse order. Both feet must land in every quadrant. Subjects are instructed to perform this pattern as quickly as possible while trying not to step on the tapes. The time taken to complete this sequence is recorded in seconds

Trial Locations

Locations (1)

Sahmyook University; 🇰🇷 Seoul, Korea, Republic of