Stroke SequelaeATFLNCT05792605
ATFL Evaluation With Ultrasound in Stroke Patients
An observational study of Stroke Sequelae, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training Ve Research Hospital
Istanbul, 34255
About this study
Official title: Comparison of Anterior Talofibular Ligament Morphology on the Affected and Unaffected Side by 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.
Read the 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.
- Conditions
- Stroke Sequelae
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior talofibular ligament(ATFL) thickness
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.
Measured: baseline
Visual assessment of anterior talofibular ligament(ATFL) signal
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.
Measured: baseline
Visual assessment of achilles tendon signal
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.
Measured: baseline
Secondary outcomes (2)
Brunstrom motor recovery stage
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.
Measured: baseline
Barthel Index
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start20 Feb 2023
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pınar Doğan, Gaziosmanpasa Research and Education Hospital
- Investigators
- ebru yilmaz yalcinkaya, Prof MD, Study director, gaziosmanpasa training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792605
- Sponsor's protocol ID
- 19
- Acronym
- ATFL
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30065479Kwon 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.
PubMed 23341388
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Talofibular Ligament Morphology on the Affected and Unaffected Side by Ultrasound in Stroke Patients
- ClinicalTrials.gov ID
- NCT05792605
- Acronym / sponsor ID
- ATFL / 19
- Conditions
- Stroke Sequelae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
2 secondary outcomes
Brunstrom motor recovery stage
Time frame: baseline
Barthel Index
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Results publication: PubMed 30065479Yildizgoren 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.
- Results publication: PubMed 23341388Kwon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ebru yilmaz yalcinkaya, Prof MD study director
gaziosmanpasa training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Sequelae, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior talofibular ligament(ATFL) thickness (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.