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Completed

NCT Number: NCT05792605

ATFL Evaluation With Ultrasound in Stroke Patients

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.

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Key information

Conditions

Stroke Sequelae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpasa Training Ve Research Hospital

Istanbul, 34255, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anterior talofibular ligament(ATFL) thickness

    Time frame: 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.

  2. Visual assessment of anterior talofibular ligament(ATFL) signal

    Time frame: 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.

  3. Visual assessment of achilles tendon signal

    Time frame: 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 outcomes

  1. Brunstrom motor recovery stage

    Time frame: 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.

  2. Barthel Index

    Time frame: 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.

Other outcomes

  1. Modified Ashworth Scale of gastrocnemius, soleus and tibialis posterior muscles

    Time frame: baseline

    The spasticity level of ankle will be measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension.

  2. Tardieu scale of gastrocnemius, soleus and tibialis posterior muscles

    Time frame: baseline

    The spasticity level of ankle will also be measured by using Tardieu Scale. The purpose of this scale is to quantify spasticity by assessing the muscle's response to different stretch velocities and by determining the spasticity angle. The scale ranges from 0 to 5 points, where 0 is equal to absence of spasticity, 5 is equal to high degree of spasticity.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Comparison of Anterior Talofibular Ligament Morphology on the Affected and Unaffected Side by Ultrasound in Stroke Patients

Acronym: ATFL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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