Clinical trial NCT05483764: Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.
Official title: Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paraplegia
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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).

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.

Primary outcomes:
measure: Ankle talar cartilage thicknesses
timeFrame: 1 day
measure: Achilles tendon thicknesses
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References: