- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792605
ATFL Evaluation With Ultrasound in Stroke Patients (ATFL)
Comparison of Anterior Talofibular Ligament Morphology on the Affected and Unaffected Side by Ultrasound in Stroke Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: pinar dogan, MD
- Phone Number: +905062374622
- Email: pinar.karagoz94@hotmail.com
Study Locations
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Istanbul, Turkey, 34255
- Gaziosmanpasa Training Ve Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline
|
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.
|
baseline
|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline
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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.
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline
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Tardieu scale of gastrocnemius, soleus and tibialis posterior muscles
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
Investigators
- Study Director: ebru yilmaz yalcinkaya, Prof MD, Gaziosmanpasa Training and Research Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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