NCT07119944

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress86%
Apr 2025Jul 2026

Study Start

First participant enrolled

April 9, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2026

Expected
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

July 1, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

older adultsgait analysispose estimationInertial Measurement Unitsreliability

Outcome Measures

Primary Outcomes (16)

  • 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.

    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.

    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.

    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.

    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 (%).

    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 (%).

    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 (%).

    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 (%).

    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.

    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.

    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.

    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.

    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 (%).

    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 (%).

    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 (%).

    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 (%).

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

Other Outcomes (3)

  • Mini-Mental Test

    Baseline

  • Timed Up and Go Test

    Baseline

  • Baseline Demographics

    Baseline

Study Arms (1)

Older Adults

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

Interventions

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.

Older Adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community dwelling older adults aged above 65

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation

Izmir, Balcova, 35330, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 1, 2025

First Posted

August 13, 2025

Study Start

April 9, 2025

Primary Completion

April 9, 2026

Study Completion (Estimated)

July 9, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations