NCT06057272

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 19, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

September 14, 2023

Last Update Submit

March 16, 2025

Conditions

Keywords

gaitkinematicforensic medicineartificial intelligenceimitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 1

  • 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.

    Day 1

Secondary Outcomes (3)

  • Pain assessment

    Day 1

  • Fatigue assessment

    Day 1

  • Mental State Assessment

    Day 1

Study Arms (3)

Forensic Medicine

Individuals with unilateral lower extremity fractures who apply to the Department of Forensic Medicine for disability rate determination and reporting

Orthopedic

In individuals with unilateral lower extremity fractures who apply to the Department of Orthopedics and Traumatology

Healthy

The healthy counterparts of the patients in the forensic medicine and orthopedic population group.

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe male participants will be included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants will be included via invitation.

You may qualify if:

  • 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
  • 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
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Physical Therapy and Rehabilitation Faculty

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Semra Topuz, Prof

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 28, 2023

Study Start

October 30, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

March 19, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations