- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157775
Shear-wave Elastography of Hip Stabilizers in Healthy Individuals
November 27, 2023 updated by: Koç University
Reliability of Ultrasound Shear-wave Elastography in Assessing Tensor Fascia Lata, Gluteus Medius, and Iliotibial Band Elasticity in Health Individuals: a Cross-sectional Study.
The aim of this study is to provide a scientific basis for Shear-wave elastography measurements of hip stabilizing muscles on healthy individuals.
To assess the inter- and intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by two experienced physiatrists.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34010
- Koc University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
12 Healthy Individuals, 4 male and 8 female.
Description
Inclusion Criteria:
- Healthy Individuals
- Age 18-30 years
- Volunteering for the study
- Absence of musculoskeletal pathologies involving pelvic, hip, and/or knee joints.
Exclusion Criteria:
- Recent complaints of pelvic, hip, and/or knee pain.
- Previous history of trauma or surgery, including the lumbar, pelvic, hip, or knee region.
- Congenital or acquired pathologies of pelvis or lower extremity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Individuals
|
Shear-wave elastography using a manual ultrasound with a 9L-Probe in B-mode.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of tensor fascia latae muscle on shear wave elastography.
Time Frame: 1 month
|
1 month
|
Assessment of gluteus medius muscle on shear wave elastography.
Time Frame: 1 month
|
1 month
|
Assessment of iliotibial band on shear wave elastography.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ozden Ozyemisci Taskiran, MD, Koc University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.
- Cortez CD, Hermitte L, Ramain A, Mesmann C, Lefort T, Pialat JB. Ultrasound shear wave velocity in skeletal muscle: A reproducibility study. Diagn Interv Imaging. 2016 Jan;97(1):71-9. doi: 10.1016/j.diii.2015.05.010. Epub 2015 Jun 25.
- Iida N, Kuroiwa T, Amadio P. Analysis of the thenar muscles with ultrasound shear wave elastography: Reliability and preliminary findings. Muscle Nerve. 2023 Nov 15. doi: 10.1002/mus.28004. Online ahead of print.
- Vuorenmaa AS, Siitama EMK, Makela KS. Inter-operator and inter-device reproducibility of shear wave elastography in healthy muscle tissues. J Appl Clin Med Phys. 2022 Sep;23(9):e13717. doi: 10.1002/acm2.13717. Epub 2022 Jul 6.
- Gyaran IA, Spiezia F, Hudson Z, Maffulli N. Sonographic measurement of iliotibial band thickness: an observational study in healthy adult volunteers. Knee Surg Sports Traumatol Arthrosc. 2011 Mar;19(3):458-61. doi: 10.1007/s00167-010-1269-z. Epub 2010 Oct 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Estimated)
December 6, 2023
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2019.347.IRB1.062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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