- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042818
Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
July 31, 2019 updated by: Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Poststroke patients often suffer from muscle atrophy in quadriceps muscle.
Quadriceps muscle is essential for independent standing or ambulation after stroke.
Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis.
The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining.
Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities.
The procedures will be repeated by two experts at two separate times (7-10 days).
For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated.
Totally 68 patients will be included in the study.
Study Type
Observational
Enrollment (Anticipated)
68
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
-
-
-
Istanbul, Turkey, 34255
- Recruiting
- Gaziosmanpasa Taksim Training and Research Hospital
-
-
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
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Poststroke patients
Description
Inclusion Criteria:
- Poststroke patients (>6 months)
Exclusion Criteria:
- < 6 months after stroke
- Multiple stroke
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thickness of Rectus Femoris Muscle
Time Frame: One week
|
Longitudinal and Transverse thickness of rectus femoris muscle
|
One week
|
Thickness of vastus intermedius muscle
Time Frame: One week
|
Longitudinal and Transverse thickness of vastus intermedius muscle
|
One week
|
Cross-sectional area of Rectus Femoris Muscle
Time Frame: One week
|
Cross-sectional area of Rectus Femoris Muscle
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ebru Y Yalçınkaya, M.D., Gaziosmanpasa Taksim Training and Research Hospital
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)
July 1, 2019
Primary Completion (ANTICIPATED)
December 30, 2019
Study Completion (ANTICIPATED)
January 30, 2020
Study Registration Dates
First Submitted
July 20, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (ACTUAL)
August 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREH7
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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