NCT07293949

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 22, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

November 22, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

spinal cord injuryosteoarthritismusculoskeletal ultrasoundtalar cartilage

Outcome Measures

Primary Outcomes (1)

  • Talar cartilage thickness

    The talar cartilage of both lower extremities are to be assessed with ultrasound

    Baseline

Secondary Outcomes (3)

  • Functional Independence Measure (FIM) score

    Baseline

  • Modified Ashworth Scale (MAS)

    Baseline

  • Walking Index for Spinal Cord Injury II (WISCI II)

    Baseline

Study Arms (2)

Patient group

Spinal cord injury patients

Control group

Age, sex, and BMI matched healthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesOsteoarthritis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 19, 2025

Study Start

December 20, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 3 years after the publication of results

Locations