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Older Adults (65 Years and Older)NCT07119944

Pose Estimation and Inertial Measurement Unit Systems for Gait Analysis in Older Adults

An observational study of Older Adults (65 Years and Older), run by Bozok University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

-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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Older Adults (65 Years and Older)
What is being tested?
Not Related
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Apr 2025to 9 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Community dwelling older adults aged above 65

Who may be able to join

  • Ability to walk independently
  • Mini-Mental State Examination (MMSE) score ≤ 23/30

Who cannot join

  • Inability to walk independently for more than 20 meters without assistive devices
  • Inability to understand or comply with test instructions
  • Lack of consent to participate
  • Presence of severe neurological, musculoskeletal, cardiac, or psychological disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation

    Izmir, Balcova, 35330

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation of Gait Analysis in Older Adults Using Pose Estimation Algorithms and an Inertial Measurement Unit-based System: a Reliability Study

-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:

Read more
  1. Are gait analyses using pose estimation algorithms consistent with those performed using an inertial measurement unit-based system in older adults?
  2. Are gait analyses using pose estimation algorithms reliable in older adults?

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.

Read the detailed description

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.

Being tested
Not Related
Keywords
older adults, gait analysis, pose estimation, Inertial Measurement Units, reliability

What participants receive

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

  • Not RelatedOther

    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.

Study groups in NCT07119944
Study groupRoleWhat they receive
Older AdultsOnly 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.
Receives: Other: Not Related

What is being measured

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

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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 (%).

    Measured: Baseline

  6. 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 (%).

    Measured: Baseline

  7. 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 (%).

    Measured: Baseline

  8. 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 (%).

    Measured: Baseline

  9. 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.

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  10. 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.

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  11. 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.

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  12. 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.

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  13. 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 (%).

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  14. 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 (%).

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  15. 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 (%).

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

  16. 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 (%).

    Measured: Baseline (first session) and 1-3 days after the baseline (second session)

Timeline

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

  1. First posted13 Aug 2025
  2. Study start9 Apr 2025
  3. Primary completion9 Apr 2026 (estimated)
  4. Study completion9 Jul 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119944
Sponsor's protocol ID
9768-GOA
Other IDs
Decision No: 2025/12-08
Status last verified
Nov 2025
First submitted
1 Jul 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Older Adults (65 Years and Older), run by Bozok University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inertial Measurement Unit (IMU)-Based Gait Analysis Parameters-Gait Speed (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 4 Nov 2026.

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