NCT05792605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

28 days

First QC Date

March 8, 2023

Last Update Submit

March 31, 2023

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    baseline

Secondary Outcomes (2)

  • Brunstrom motor recovery stage

    baseline

  • Barthel Index

    baseline

Other Outcomes (2)

  • Modified Ashworth Scale of gastrocnemius, soleus and tibialis posterior muscles

    baseline

  • Tardieu scale of gastrocnemius, soleus and tibialis posterior muscles

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training Ve Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30065479RESULT

  • 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.

    PMID: 23341388RESULT

Study Officials

  • ebru yilmaz yalcinkaya, Prof MD

    gaziosmanpasa training and research hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 31, 2023

Study Start

February 20, 2023

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)