Ultrasonographic Evaluation of Talar Cartilage Thickness in Patients With Spinal Cord Injury

July 25, 2026 updated by: Gaziosmanpasa Research and Education Hospital

Ultrasonographic Evaluation of Talar Cartilage Thickness in Patients With Spinal Cord Injury: A Cross-Sectional Case-Control Study

Spinal cord injury patients often present with musculoskeletal comorbidities, including osteoarthritis. Early detection of cartilage damage is important for preventing osteoarthritis progression. This study aims to compare the talar cartilage thicknesses of spinal cord injury patients with healthy subjects. The secondary aim is to investigate a correlation between the talar cartilage thickness and disease-related parameters. The patient group is to be assessed for talar cartilage thickness (via ultrasound), functional status, spasticity, and ambulation levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Gaziosmanpasa Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Thirty-eight SCI patients who apply to Physical Medicine and Rehabilitation outpatient and inpatient clinic between November 2025-January 2026 will be included in the study.

Thirty-eight age, gender, and BMI-matched healthy participants who are literate, give oral and written consent without any additional disease will be formed as the control group.

Description

Inclusion Criteria:

  • Aged between 18 to 60 years,
  • Cervical, thoracal or lumber level of spinal cord injury
  • AIS (American Spinal Injury Association Impairment Scale) Level A, B, C, or D
  • Assisted ambulation of any kind
  • Literacy
  • Giving oral and written consent to participate in the study

Exclusion Criteria:

  • Patients with sacral level injury
  • AIS E
  • MAS 4 level of spasticity
  • History of any lower extremity operation
  • History of fracture
  • Botulinum toxin injection in the last 6 months
  • Existing diagnosis of any rheumatologic or endocrine diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patient group
Spinal cord injury patients
Control group
Age, sex, and BMI matched healthy controls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Talar cartilage thickness
Time Frame: Baseline
The talar cartilage of both lower extremities are to be assessed with ultrasound
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM) score
Time Frame: Baseline
Functional Independence Measure scores will be held for the patient group in order to assess functional independence. This 18-item scale ranges between 18-126, higher scores indicating better outcomes.
Baseline
Modified Ashworth Scale (MAS)
Time Frame: Baseline
The spasticity level of patients are to be recorded for both ankle flexor and extensors via Modified Ashworth Scale. This scale ranges from 0 to 4; 0 indicating no spasticity, and 4 indicating severe increase in muscle tone with rigid joint.
Baseline
Walking Index for Spinal Cord Injury II (WISCI II)
Time Frame: Baseline
Ambulatory status of the patients will be recorded with this measuring scale, ranging between 0 (non ambulatory) to 20 (able to walk 10 meters with no devices/orthosis/assistance).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziosmanpasa Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets of the study (patient and volunteer demographics, clinical data, and statistical data) will be shared after completion of the study with third parties upon reasonable request.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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