NCT05483764

Brief Summary

Investigators aim to measure the ankle talar cartilage and achilles tendon thicknesses ultrasonographically in paraplegic patients and compare them with the normal population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

July 28, 2022

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ankle talar cartilage thicknesses

    Patients will lie on the examination table supine with their knees flexed to 90 degrees and ankles in a flat-footed position. The probe was placed mid-longitudinally over the ankle joint to assess the cartilage of the talar dome. The articular cartilage will be displayed as an anechoic line between bony cortex and adipose tissue. Cartilage thickness will be measured by drawing a straight line from the bone-cartilage interface to the cartilage-fatty tissue interface at the midpoint of the talar dome. The thickness of the hyaline cartilage will be measured in centimeters (cm).

    1 day

  • Achilles tendon thicknesses

    Ultrasound (US) evaluation will be performed with patients in the prone position on examination table with their feet in 90 degrees of flexion. Achilles tendon of the each patient and healthy volunteer will be scanned. Antero-posterior achilles thickness will be measured on the same mid-longitudinally scan at two different levels: at the insertion of the achilles tendon deeper edge into the calcaneal bone and 3 cm more proximal. The thickness of the achilles tendon will be measured in centimeters (cm).

    1 day

Study Arms (2)

Paraplegia

Device: Ultrasonographic evaluations

Control

Device: Ultrasonographic evaluations

Interventions

Ultrasonographic evaluations of the talar cartilage will be performed with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) by the same physiatrist according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS). Ultrasonographic evaluations of the Achilles tendon will be performed by the same physiatrist with an 8 MHz linear probe (B-K Medical Ultrasound Scanner Class I Type B) according to the European Musculoskeletal Ultrasound Study Group (EURO-MUSCULUS).

ControlParaplegia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The control group will be composed of healthy individuals who are compatible with the patient group in terms of age, gender and weight.

You may qualify if:

  • Patients who are paraplegic after traumatic spinal cord injury (ASIA A-D)
  • Healthy volunteers older than 18 years for control patients.

You may not qualify if:

  • Patients who had a previous trauma-related operation on the ankle.
  • Patients who had fixed contracture or severe spasticity on the ankle.
  • Patients who had lower-limb length difference of more than 2 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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 28, 2022

First Posted

August 2, 2022

Study Start

August 1, 2022

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations