Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.

Active, not recruiting

• Conditions: Paraplegia
• Interventions: Device: Ultrasonographic evaluations

• Registration Number: NCT05483764
• Lead Sponsor: Abant Izzet Baysal University

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.

Detailed Description

Paraplegia is a clinical condition that expresses the loss of motor and sensory function in the lower extremities after spinal cord injury. A specialized and intensive rehabilitation program is needed in these patient groups who develop immobilization. In healthy individuals, there is a certain biomechanics of the lower extremity. In paraplegic patients, this biomechanics changes due to weakness in the lower extremities. These biomechanical changes can cause different loads and effects on the lower extremity joints, muscles, tendons, and articular cartilages of paraplegic patients. Among the rehabilitation goals of paraplegic patients, it is to stand up and walk the patient with or without support, with or without a device. During this rehabilitation, the position and function of the ankle is important. In this process, the talar condylar cartilage and achilles tendon forming the ankle joint can be exposed to different loads.

Ultrasonography is frequently used in physical therapy practice because it does not contain any radiation, has no side effects to the patient, facilitates dynamic and real-time evaluation of joint and muscle conditions and functions, and provides guidance during interventional procedure planning. In this study, investigators aim to ultrasonographically measure ankle talar cartilage and Achilles tendon thicknesses in paraplegic patients with long-term immobilization and compare them with the normal population.

Our study will be organized as a observational study. It is planned to include 20 paraplegia patients and 20 healthy volunteers in the study.

Demographic data of the patients and healthy volunteers will be recorded. Paraplegia patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, American Spinal Injury Association (ASIA) scale, Walking Index for Spinal Cord Injury Scale (WISCII-2).

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study Start: 2022-08-01
• Study First Posted: 2022-08-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paraplegia	Ultrasonographic evaluations	-
Control	Ultrasonographic evaluations	-

Primary Outcome Measures

Name	Time	Method
Ankle talar cartilage thicknesses	1 day	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).
Achilles tendon thicknesses	1 day	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).

Trial Locations

Locations (1)

Abant Izzet Baysal University; 🇹🇷 Bolu, Turkey