NCT05361928

Brief Summary

Our objective is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of mucles of patients with and without hamstring injury. 76 patients will be evaluated cross sectionally twice by two ultrasonographists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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

January 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 1, 2022

Last Update Submit

May 1, 2022

Conditions

Keywords

muscle

Outcome Measures

Primary Outcomes (1)

  • Elasticity

    ultrasound

    Inclusion

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients justifying an ultrasound evaluation for suspicion of muscle injury

You may qualify if:

  • Patients justifying an ultrasound evaluation for suspicion of muscle injury

You may not qualify if:

  • Inflammatory muscle disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Study Design

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

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 5, 2022

Study Start

January 10, 2021

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Yes All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three month and ending five years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations