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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Validity and Reliability of a Novel Depth Camera-based Physical Function and Fall Risk Assessments for Community Dwellings Elders Living Alone

Conditions

Fall, Healthy Aging

Being tested

Azure Kinect-based Tandem Stance Test (ATST) and Physical Therapist's Measurements of Tandem Stance Test (PTST), Azure Kinect-based Five Times Sit-to-Stand Test (AFTSS) and Physical Therapist's Measurements of Five Times Sit-to-Stand Test (PFTSS), Azure Kinect-based Timed Up and Go Test (ATUG) and Physical Therapist's Measurements of Timed Up and Go Test (PTUG), Short Physical Performance Battery (SPPB), Berg Balance Scale (BBS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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

• 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

  The Five Times Sit-to-Stand Test (FTSS), standardized by Csuka and McCarty, has been designed to assessing lower limb strength as well as balance and postural control among elder population with high level of reliability. A previous study reported excellent intra-rater reliability (ICC=.914-.933) and inter-rater reliability (ICC=.988-.995) among healthy older adults. In addition, Five Times Sit-to-Stand Test more than 11.50 seconds had been reported to represent risk of falls among elders over 65-year-old. To assess Five Times Sit-to-Stand Test , a chair, 45cm in height and fixed to the ground, was placed three meters from the camera. Participants began seated, and on start cue, repeatedly stood up and sat down five times. The Azure Kinect-based system automatically ended its measurement as the participant completed the fifth stand, whereas the physical therapist manually measured time using the stopwatch. The time measures from the system and therapist were compared.

• Azure Kinect-based Timed Up and Go Test (ATUG) and Physical Therapist's Measurements of Timed Up and Go Test (PTUG)Diagnostic test

  The Timed Up and Go test (TUG) has been employed as a straightforward assessment of an individual's mobility, necessitating both static and dynamic balance. A Timed Up and Go test duration exceeding 9.50 seconds has been identified as indicative of a heightened fall risk in individuals aged 65 and older. A previous study reported excellent intra-rater reliability (ICC=.97) and inter-rater reliability (ICC=.96). Initiating in a seated position, participants stood upon commencement of the test. Simultaneously, the Azure Kinect-based system and stopwatch began the time measurements. Participants then walked a distance of three meters, turned around, retraced their steps, and resumed their seated position. The Azure Kinect-based system automatically terminated its timing once the participant was seated, while the physical therapist manually stopped the stopwatch. The time measures from the system and therapist were compared.

• Short Physical Performance Battery (SPPB)Diagnostic test

  The assessment includes three tests: a Timed Up and Go test test where participants walked a distance of 3 meters at their comfortable pace; a Five Times Sit-to-Stand Test which the duration is also measured; and the standing balance test which determines a participant's capacity to maintain three different stances of side-by-side, semi-tandem, and full tandem, each for 10 seconds.

• Berg Balance Scale (BBS)Diagnostic test

  Participants are scored on a 5-point scale for each task, where a score of 0 signifies an inability to perform, while a 4 denotes independence in execution. A perfect score of 56 is a marker of excellent balance. Administering the Berg Balance Scale is efficient, taking between 10 to 20 minutes, and requires only basic equipment such as a chair, stopwatch, ruler, and step within a small space.

• Functional Reach Test (FRT)Diagnostic test

  Participants, standing barefoot, aligned the side of their body with a wall, ensuring no contact. Their stance was parallel with feet comfortably spaced. With their shoulders flexed at a 90° angle adjacent to the wall, they kept their elbows straight and hands clenched. The starting point on a horizontally affixed measuring tape, level with the floor, was determined by where the third metacarpal touched. This tape was aligned with each participant's acromion height. Without taking a step, lifting heels or losing balance, participants leaned forward to their maximum extent. The difference between the initial and final third metacarpal positions on the tape denoted the reach distance.

• Four-Square Step Test (FSST)Diagnostic test

  During the Four-Square Step Test, participants were instructed to step over four straight tapes, each 90 cm in length, laid out in a cross-shape configuration on the floor. Beginning in square 1 and facing square 2, participants followed a specific sequence: they stepped forward into the next quadrant, then to the right, backward, and finally to the left, moving in a clockwise direction. This sequence was then retraced in a counterclockwise manner. It was essential for both feet to touch down in each quadrant. Participants aimed to complete this pattern as fast as they could, avoiding stepping the tapes. The duration taken to finish the sequence was recorded.

• Grip Strength (GS)Diagnostic test

  The strength of the dominant hand's maximal grip force, indicative of upper extremity muscle strength, was gauged using a digital isometric hand dynamometer.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: baseline

2. 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.

   Measured: baseline

3. 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.

   Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Jul 2024
2. Study start1 Aug 2023
3. Primary completion22 Oct 2023
4. Study completion31 Dec 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for FallStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.