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Gait, StumblingNCT06057272

Lie Detector At the Gait: Artificial Intelligence Model

An observational study of Gait, Stumbling and Fracture Lower Leg, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to obtain more consistent results with the use of repetitive neural networks in gait models and classification approaches in individuals applying forensic sciences. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2023to 30 Dec 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: The participants will be included via invitation.

Who may be able to join

  • Applying to the Department of Forensic Medicine to determine the disability rate,
  • Antalgic gait evaluation performed within the scope of traffic accident or disability reporting,
  • Having a history of unilateral lower extremity fracture,
  • Not having any orthopedic or neurological problems that may affect walking, other than fractures,
  • At least 6 months after surgical treatment,
  • Scoring 24 or more from the Standardized Mini Mental Test
Show all 18Show fewer
  • Male individuals between the ages of 18-40
  • Having a history of unilateral lower extremity fracture,
  • Not in a position of disability or compensation after the fracture,
  • Treated in the Orthopedics and Traumatology Department
  • Similar to the participants in the Group Forensic Medicine in terms of demographic characteristics,
  • No orthopedic or neurological problems other than fractures that would affect walking,
  • At least 6 months after surgical treatment,
  • Scoring 24 or above from the Standardized Mini Mental Test,
  • Male individuals between the ages of 18-40
  • Healthy participants who have compatible demographic characteristics of the patient groups,
  • Scoring 24 or more from the Standardized Mini Mental Test,
  • Male individuals between the ages of 18-40.

Who cannot join

  • Having any problems or pain in the upper extremities and/or trunk,
  • Having problems in both lower extremities,
  • Treatment is ongoing,
  • Patients who do not have the ability to walk independently,
  • Having a Body Mass Index of 30 kg/m² and above.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University Physical Therapy and Rehabilitation Faculty

    Ankara, Samanpazarı, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Determination of Walking Imitations with Artificial Intelligence Model in Forensic Medicine; Lie Detector for Walking

The goal of this clinical trial is to obtain more consistent results with the use of repetitive neural networks in gait models and classification approaches in individuals applying forensic sciences. It was aimed to develop a decision support system for determining the walking imitations of individuals with explainable machine learning approaches on disability compensation in the field of Forensic Medicine.

Participants will be assessed regarding kinematic and temporospatial gait parameters, pain severity, and fatigue level.

Comparison group: Researchers will compare the patients applying to the forensic medicine department to those applying to the orthopedic department, and their healthy counterparts.

Read the detailed description

Walking is an autonomic process that involves repetitive cycles and occurs as a result of rhythmic alternating movements of the trunk, upper and lower limbs, and the forward displacement of the gravity center in the sagittal plane. Gait assessments in locomotor diseases or situations that affect movements are based on the description of the individual's gait characteristics and comparison of reference data of individuals of similar age and sex.

In some cases, patients do not walk with their real gait pattern, but may use imitation of some pathologic patterns for secondary financial expectations. Generally, this problem, which can be experienced when determining the disability rate in the field of Forensic Medicine, is carried out in order to deliberately deflect the person's walk and to achieve a higher disability rate. Thus, some unfair compensation gains may occur. It is expected that there will be consistency in repetitive steps during a person's habitual gait, however, this consistency between steps is expected to differ if one wishes to imitate a gait. If this issue will provide benefits especially in terms of disability compensation, imitation is difficult to understand and proved with methodological designs developed for gait analysis and observational analysis and is often inadequate.

In recent studies, deep neural networks have been used to study the uniqueness of individual gait patterns by learning and classifying nonlinear systems from data collected from multiple sensors. More successful results are obtained with 3-dimensional kinematic data instead of only 2-dimensional spatial-temporal relationship by using information obtained from many sensors in gait analysis with depth images and inertial measurement units. Based on this, within the scope of the study, it is aimed to obtain more consistent results with the use of repetitive neural networks in gait models and classification approaches.

It is especially important in clinical evaluations that the analysis and effective features of the models developed with the studies in the field of explainable artificial intelligence and present clear findings to the decision maker. The only study that contains similarities about the study to be conducted is the use of layer-by-layer relationship propagation approach to explain walking patterns in individuals with deep learning methods. Within the scope of this project, it was aimed to develop a decision support system for determining the walking imitations of individuals with explainable machine learning approaches on disability compensation in the field of Forensic Medicine. In this way, regardless of the personal experience of the evaluator and the method, it will be ensured that unfair compensation or lost rights gained by imitation walk is prevented and evidence-based information for the benefit of justice in judicial processes will be obtained.

The study will make a significant contribution to the field and the literature as the first study in which artificial intelligence model is used in the determination of walking imitations in the field of Forensic Medicine and which creates a decision support system (lie detector on the walk) in this field. The spatiotemporal characteristics and kinematic evaluations of gait in diseases affecting movement and in healthy individuals are frequently used in clinics and researches in medicine and health sciences, but this project is for the first time in the field of medicine to use multiple gait data in an artificial intelligence model to distinguish imitation gaits. With the creation of the artificial intelligence model, it will contribute to academic studies and researcher training for the definition of disease specific gait patterns and the creation of norms in the following stages.

Keywords
gait, kinematic, forensic medicine, artificial intelligence, imitation
Medical subject headings
Gait Disorders, Neurologic

What participants receive

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

Study groups in NCT06057272
Study groupRoleWhat they receive
Forensic MedicineIndividuals with unilateral lower extremity fractures who apply to the Department of Forensic Medicine for disability rate determination and reporting
OrthopedicIn individuals with unilateral lower extremity fractures who apply to the Department of Orthopedics and Traumatology
HealthyThe healthy counterparts of the patients in the forensic medicine and orthopedic population group.

What is being measured

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

  1. Kinematic Gait analysis

    During walking, angular values of the lower and upper limbs and trunk will be measured simultaneously with the measurement of time distance characteristics.

    Measured: Day 1

  2. Temporospatial gait analysis

    Individuals' gait will be assessed using the GAITRite® computerized walking path (CIR System INC. Clifton, NJ 07012). Data from the system, which has 18,432 sensors, is obtained by pressure-activated sensors at a rate of 60-120 Hz. In order to eliminate the learning effect, the subjects will be asked to walk at the pace they choose after three attempts are made. Rest breaks will be given between assessments and the average of three repetitions of the walk will be recorded.

    Measured: Day 1

Secondary outcomes (3)
  1. Pain assessment

    Visual Analogue Scale will be used to evaluate the pain severity of individuals. Participants will be asked to mark their pain at rest and activity on a horizontal line of 100 millimeters, with 100 indicating maximum pain and 0 indicating no pain.

    Measured: Day 1

  2. Fatigue assessment

    Visual Analogue Scale will be used to evaluate the fatigue level of individuals. Participants will be asked to mark their fatigue level at rest and activity on a horizontal line of 100 millimeters, with 100 indicating maximum pain and 0 indicating no pain.

    Measured: Day 1

  3. Mental State Assessment

    To evaluate the mental state of the patients, Mini Mental Test will be used.Mini-mental test scores can vary between 0-30. Scores of 25 and above are considered normal.

    Measured: Day 1

Timeline

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

  1. First posted28 Sep 2023
  2. Study start30 Oct 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Dec 2024

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
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057272
Sponsor's protocol ID
GO21/749
Status last verified
Jul 2024
First submitted
14 Sep 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

An observational study of Gait, Stumbling and Fracture Lower Leg, run by Hacettepe 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 18 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Kinematic Gait analysis (time frame: Day 1). The study lists 2 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 19 Mar 2025.

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