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

NCT ID: NCT05483764

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-03-30

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).

Conditions

Paraplegia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Paraplegia

Ultrasonographic evaluations

Intervention Type: DEVICE

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).

Control

Ultrasonographic evaluations

Intervention Type: DEVICE

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).

Interventions

Ultrasonographic evaluations

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Kilinc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-SK-03

Identifier Type: -

Identifier Source: org_study_id