ATFL Evaluation With Ultrasound in Stroke Patients

Completed

• Conditions: Stroke Sequelae

• Registration Number: NCT05792605
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

ATFL thickness increases on the affected side of stroke patients and the homogeneous fibrillar structure is deteriorated.We aim to compare morphology of ATFL and Achilles tendon on the affected and unaffected sides using ultrasound in hemiplegic patients.

Detailed Description

Age, gender, BMI, time elapsed after the event (months), Brunstrom motor stages and Barthel Activities of Daily Living index of the patients will be recorded. Modified Ashworth Scale and Tardieu scale are used to determine the muscle tone in the gastrocnemius, soleus and tibialis posterior of the hemiplegic side.

ATFL and Achilles tendon will be evaluated using a 12 MHz linear probe of the Toshibo Aplio 500 USG device.ATFL and Achilles tendon signal will be evaluated with reference to contralateral features.

ATFL will be evaluated while the patient lying in the supine position with knee flexion and ankle slight plantarflexion and inversion.The probe will be placed anterolaterally between the lateral malleolus and the talus and a longitudinal image of the ATFL is obtained.

Achilles tendon will be evaluated with the patient lying in the prone position and the ankle at 90 degrees neutral.

ATFL and Achilles tendon signal will be evaluated and noted as homogeneous normal fibrillary structure or heterogeneous.All ultrasound measurements will be performed twice with the patients in the same position.

Study Timeline

• Study Start: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-19
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Study First Posted: 2023-03-31
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients suffering cerebrovascular accident associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
• Patients over the age of 18

Exclusion Criteria

• Patients who were medically unstable
• Patients who had Botulinum Toxin A injection into any muscle in the last 6 months
• Patients who had other systemic neuromuscular disease
• Patients who had a previous orthopedic or neuromuscular injury to the lower extremity
• Patients who had a skin lesion at the measurement site

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior talofibular ligament(ATFL) thickness	baseline	ATFL will be evaluated using a 12 MHz linear probe of the Toshibo Aplio 500 USG device. The thickness in millimeters will be measured from the midpoint of the ligament on the affected and unaffected side. Thicknesses will be compared and whichever side is thicker will be considered as increased in thickness. Being thicker is worse, indicating degenerative process.
Visual assessment of anterior talofibular ligament(ATFL) signal	baseline	ATFL signal on the affected and unaffected side will be compared with ultrasound. ATFL signal will be evaluated and noted as homogeneous normal fibrillary structure or heterogeneous. It is worse when the ligament and tendon lose their homogeneous fibrillar structure and gain a heterogeneous appearance.
Visual assessment of achilles tendon signal	baseline	Achilles tendon signal on the affected and unaffected side will be compared with ultrasound. Achilles tendon signal will be evaluated and noted as homogeneous normal fibrillary structure or heterogeneous. It is worse when the ligament and tendon lose their homogeneous fibrillar structure and gain a heterogeneous appearance.

Secondary Outcome Measures

Name	Time	Method
Brunstrom motor recovery stage	baseline	The Brunnstrom stage describes the sequence of motor development and reorganization of the brain after stroke which contains 3 items for the arm, the hand, and the leg. The stage ranges from 1 (maximum possible impairment) to 7 (no impairment). As the patient's condition improves, the stage increases.
Barthel Index	baseline	The Barthel Index is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored, a higher number being a reflection of greater ability to function independently. Total scores on the Barthel index may range from 0-100 points, with a maximum score of 100 points indicating better performance.

Trial Locations

Locations (1)

Gaziosmanpasa Training Ve Research Hospital; 🇹🇷 Istanbul, Turkey