Clinical trial NCT05792605: ATFL Evaluation With Ultrasound in Stroke Patients
Official title: Comparison of Anterior Talofibular Ligament Morphology on the Affected and Unaffected Side by Ultrasound in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Sequelae
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who apply to the Physical Medicine and Rehabilitation Clinic of Gaziosmanpaşa Training and Research Hospital between 20.02.2023- 20.03.2023 and who had hemiplegia or hemiparesis after their first cerebrovascular accident (CVO) will be included.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anterior talofibular ligament(ATFL) thickness
timeFrame: baseline
measure: Visual assessment of anterior talofibular ligament(ATFL) signal
timeFrame: baseline
measure: Visual assessment of achilles tendon signal
timeFrame: baseline
Secondary outcomes:
measure: Brunstrom motor recovery stage
timeFrame: baseline
measure: Barthel Index
timeFrame: baseline
Other outcomes:
measure: Modified Ashworth Scale of gastrocnemius, soleus and tibialis posterior muscles
timeFrame: baseline
measure: Tardieu scale of gastrocnemius, soleus and tibialis posterior muscles
timeFrame: baseline
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training Ve Research Hospital
Study officials:
affiliation: gaziosmanpasa training and research hospital
name: ebru yilmaz yalcinkaya, Prof MD
role: STUDY_DIRECTOR
References:
citation: Yildizgoren MT, Velioglu O, Demetgul O, Turhanoglu AD. Assessment of the Anterior Talofibular Ligament Thickness in Patients with Chronic Stroke: An Ultrasonographic Study. J Med Ultrasound. 2017 Jul-Sep;25(3):145-149. doi: 10.1016/j.jmu.2017.03.001. Epub 2017 Mar 23.
citation: Kwon DR, Park GY. Differences in lateral ankle ligaments between affected and unaffected legs in children with spastic hemiplegic cerebral palsy. J Ultrasound Med. 2013 Feb;32(2):313-7. doi: 10.7863/jum.2013.32.2.313.