An observational study in Older Adults (65 Years and Older), sponsored by Bozok University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Bozok University · Observational
-This observational study aims to compare gait analysis performed using pose estimation algorithms with inertial measurement unit (IMU)-based gait analysis in older adults. Additionally, it aims to determine the reliability of gait analysis using pose estimation algorithms in this population.
The main questions it aims to answer are:
Participants will take part in two measurement sessions. In the first session, they will be evaluated for inclusion criteria and general health status, and will complete gait analysis using both G-Walk (BTS Bioengineering) IMU sensors and a standard video camera simultaneously. In the second session, scheduled 1-3 days later, participants will perform only the 4-meter walking test, which will be recorded by video for pose estimation analysis.
The primary objective of this observational study is to compare spatio-temporal gait parameters obtained from 2D pose estimation algorithms with those measured by inertial measurement units (IMUs) in older adults. A secondary aim is to evaluate the test-retest reliability of pose estimation-based gait analysis within this population.
Study Type and Sample Size This is an observational study. Based on clinical guidelines and recent instrumental research comparing validity and measurement methods in the literature, the sample size is determined to be at least 30 participants. Volunteers meeting the inclusion criteria will be recruited from patient relatives visiting the Faculty of Physical Therapy and Rehabilitation at Dokuz Eylul University for treatment.
Data Source and Collection No external data sources will be used. Assessments will be conducted via on-site visits. Any incomplete assessment will be considered as missing data. All collected data will be anonymized and stored on a password-protected institutional server. Access will be restricted to authorized research personnel.
Procedure After collecting sociodemographic data, medical history, and past medical records, participants will be screened using the Mini-Mental State Examination (MMSE) and the Timed Up and Go (TUG) test to determine eligibility. For the TUG test, participants will be asked to stand up from an armchair with armrests, walk a distance of 3 meters at a normal pace, turn around, return, and sit down. The time taken will be recorded in seconds. The TUG and MMSE test will be used to screen for basic mobility and functional balance, and to ensure that participants have sufficient physical and mental ability to complete gait trials safely.
In the primary assessment, all participants will undergo a simultaneous 4-meter walk test recorded using both G-Walk (BTS Bioengineering) IMU sensors and a standard video camera. The videos collected simultaneously with the G-Walk measurements will be processed with pose estimation algorithms for gait analysis to extract spatio-temporal gait parameters. To assess test-retest reliability of the pose estimation-based gait analysis (YOLO V.11-Pose Estimation), the same 4-meter walking test using only video recording will be repeated 1 to 3 days later in a subset of participants. Missing data will be documented and addressed accordingly.
IMU-Based Gait Analysis (G-WALK) Inertial measurement unit (IMU)-based gait analysis will be conducted using the BTS G-WALK system, a validated tool for assessing dynamic spatiotemporal gait parameters. Following the recording of demographic data (age, sex, height, weight, and shoe size), the device will be affixed at the level of the S1 vertebra using an adjustable belt. Participants will be instructed to walk a 4-meter straight path marked on the floor. The system will compute the following gait parameters: gait speed (m/s), cadence (steps/min), step length (m), step time (s), stance phase (% of gait cycle), swing phase (% of gait cycle), double support phase (% of gait cycle), single support phase (% of gait cycle).
Gait Analysis via Pose Estimation Algorithms Synchronized video recordings taken concurrently with G-WALK assessments will be used for pose estimation-based gait analysis. Videos will be trimmed to align with the temporal segment corresponding to the G-WALK data. The pose estimation algorithm used will be YOLOv11X-Pose, with a confidence threshold set at 0.25. This custom-built algorithm detects and tracks 17 key joint landmarks on the human body in 2D during walking sequences. The system will extract the same spatiotemporal gait parameters as the IMU-based method (speed, cadence, step length, etc.) by applying a custom algorithm to analyze dynamic joint trajectories. This standardization enables direct comparison between the two measurement methods. The extracted gait features will include: gait speed (m/s), cadence (steps/min), step length (m), step time (s), stance phase (% of gait cycle), swing phase (% of gait cycle), double support phase (% of gait cycle), single support phase (% of gait cycle).
Statistical Analysis Software All analyses will be conducted using SPSS version 27.0 for Windows.
Descriptive Statistics Data will be presented as frequencies. If parametric assumptions are met, means and standard deviations will be reported; otherwise, medians and interquartile ranges will be used.
Comparative Statistics Gait metrics obtained via inertial measurement unit (IMU)-based gait analysis and pose estimation algorithms will be compared. If parametric assumptions are met, paired t-tests will be used; otherwise, Wilcoxon signed-rank tests will be performed. Agreement between measurement methods will be evaluated using Bland-Altman plots and regression analysis.
Reliability Statistics Test-retest reliability of the pose estimation algorithm will be assessed. A subgroup of 30 randomly selected participants will undergo a second 4-meter walk video recording 1 to 3 days after the initial assessment. Agreement between test and retest measurements will be analyzed using Intraclass Correlation Coefficients (ICC).
Handling of Missing Data If participants withdraw at any point or fail to complete assessment procedures properly, data from those participants will be excluded from further analysis.
Bozok University is the lead sponsor of 53 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community dwelling older adults aged above 65
Exclusion Criteria:
Only one group of participants is included in this study, since the focus is on evaluating and comparing two gait analysis measurement techniques within the same individuals.
Other: Not Related
This observational study does not involve any therapeutic intervention. Instead, all participants undergo gait analysis using two different measurement methods-2D pose estimation algorithms and an inertial measurement unit (G-Walk system)-to compare their outputs. Both assessments are performed on the same individuals under standardized conditions without altering their routine care.
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Gait Speed
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. The system will measure walking speed as meters/second.
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Cadance
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. The system will measure cadence as steps/minute.
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Step Length
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. The system will measure step length as meters.
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Step Duration
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. The system will measure step duration as seconds.
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Stance Time
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. Stance time will be measured by the system and expressed as a percentage of the gait cycle (%).
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Swing Time
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. Swing time will be measured by the system and expressed as a percentage of the gait cycle (%).
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Double Support Time
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. Double support time will be measured by the system and expressed as a percentage of the gait cycle (%).
Time frame: Baseline
Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Single Support Time
Gait analysis will be performed using the BTS G-WALK device, a validated and reliable inertial measurement unit (IMU)-based system. The device will be securely attached at the level of the S1 vertebra using a belt. Start and end points will be marked on the floor, and participants will be asked to walk a distance of 4 meters. Single support time will be measured by the system and expressed as a percentage of the gait cycle (%).
Time frame: Baseline
Gait Analysis Using Pose Estimation Algorithms-Gait Speed
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To allow valid comparison with the IMU-based system, the algorithm will derive gait speed as meters/second.
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Cadance
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To allow valid comparison with the IMU-based system, the algorithm will derive the cadence as steps/minute.
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Step Length
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To allow valid comparison with the IMU-based system, the algorithm will derive step length as meters.
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Step Duration
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To allow valid comparison with the IMU-based system, the algorithm will derive the step duration as seconds.
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Stance Time
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To enable valid comparisons with the IMU-based system, the algorithm will calculate stance time and express it as a percentage of the gait cycle (%).
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Swing Time
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To enable valid comparisons with the IMU-based system, the algorithm will calculate swing time and express it as a percentage of the gait cycle (%).
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Double Support Time
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To enable valid comparisons with the IMU-based system, the algorithm will calculate double support time and express it as a percentage of the gait cycle (%).
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Gait Analysis Using Pose Estimation Algorithms-Single Support Time
Video recordings captured simultaneously with the inertial measurement unit (IMU)-based gait analysis system will be processed using a pose estimation algorithm. To ensure temporal alignment with the BTS G-WALK system, the videos will be trimmed and synchronized accordingly. The YOLO 11X-Pose algorithm version 0.25 with a threshold score will be employed for pose estimation. This algorithm dynamically tracks 17 key joint points on the body diagram during gait to extract dynamic gait parameters. To enable valid comparisons with the IMU-based system, the algorithm will calculate single support time and express it as a percentage of the gait cycle (%).
Time frame: Baseline (first session) and 1-3 days after the baseline (second session)
Mini-Mental Test
The Mini-Mental State Examination (MMSE), a validated and reliable cognitive assessment tool for older adults, will be used to evaluate participants' cognitive status. The test consists of 30 questions covering subdomains such as orientation, registration, language, attention, calculation, and recall, with a maximum possible score of 30 points.
Time frame: Baseline
Timed Up and Go Test
During the timed up and go test, participants will be asked to stand up from an armchair with armrests, walk a distance of 3 meters at a normal pace, turn around, return, and sit down. The time taken will be recorded in seconds.
Time frame: Baseline
Baseline Demographics
Demographic and anthropometric data, including age (years), gender (female/male/non-binary), height (cm), weight (kg), and shoe size (EU standard), will be collected during the baseline session to describe the participant characteristics. Additionally, body mass index (BMI) will be calculated from height and weight and reported in kg/m².
Time frame: Baseline
Plan to share: No — Since gait assessment of older adults using video analysis has been completed, data protection regulations in our country, particularly regarding video data, are strictly followed in accordance with the Personal Data Protection Law.
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