NCT06157775

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

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

October 31, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

November 20, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of tensor fascia latae muscle on shear wave elastography.

    1 month

  • Assessment of gluteus medius muscle on shear wave elastography.

    1 month

  • Assessment of iliotibial band on shear wave elastography.

    1 month

Study Arms (1)

Healthy Individuals

Diagnostic Test: Shear-wave elastography

Interventions

Shear-wave elastography using a manual ultrasound with a 9L-Probe in B-mode.

Healthy Individuals

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

12 Healthy Individuals, 4 male and 8 female.

You may qualify if:

  • Healthy Individuals
  • Age 18-30 years
  • Volunteering for the study
  • Absence of musculoskeletal pathologies involving pelvic, hip, and/or knee joints.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 26119864BACKGROUND
  • Iida N, Kuroiwa T, Amadio P. Analysis of the thenar muscles with ultrasound shear wave elastography: Reliability and preliminary findings. Muscle Nerve. 2024 Jan;69(1):72-77. doi: 10.1002/mus.28004. Epub 2023 Nov 15.

    PMID: 37964671BACKGROUND
  • 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.

    PMID: 25029916BACKGROUND
  • 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.

    PMID: 35793227BACKGROUND
  • 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.

    PMID: 20890700BACKGROUND

Study Officials

  • Ozden Ozyemisci Taskiran, MD

    Koc University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 6, 2023

Study Start

October 31, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 6, 2023

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations