- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04755257
Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles
February 11, 2021 updated by: caglar soylu, Ankara Yildirim Beyazıt University
Today, the most commonly used position is the seated position with 45° of shoulder abduction (Abd) in the scapular plane, known as the most functional isokinetic assessment of shoulder-rotator strength (1).
However, considering the architectural feature of the rotator muscles, a position where the maximum sarcomere length is obtained, in which the maximum muscle strength is produced, has not been investigated.
Ward et al. showed that the shoulder position, in which the sarcomere length of the muscles was between 2.0 - 2.6 µm, was 25⁰ Abd and 20⁰ external rotation (ER) as a result of their study on the rotator cuff muscles architecture (2).
The test position selected in isokinetic measurements is the main factor for outcome measurements and the repeatability of the measurements directly depends on the selected position (3).
This study was planned to investigate the effects of the position where the shoulder is at 25⁰ Abd and 20⁰ ER to develop the most suitable isokinetic strength evaluation position based on muscle architecture for shoulder rotator muscles.Using IsoMed 2000 device (D. & R. Ferstl GmbH, Hemau, Germany) we conducted the isokinetic test of concentric (CON) and eccentric (ECC) shoulder internal (IR) and external (ER) strength at the angular velocity of 60˚/s in both Method I (scapular position) and Method II (25⁰ Abd and 20⁰ ER).
There were seven days between the testing sessions, and both tests were conducted at the same time of day.
The same examiner with experience in performing isokinetic testing with IsoMed 2000 tested all subjects in both testing sessions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
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
-
-
Etlik
-
Ankara, Etlik, Turkey, 06010
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
healthy male subjects
Description
Inclusion Criteria:
- Being between the ages of 18-25
- Body mass index (BMI) being between 18.5-24.9 kg / m 2
- Volunteering to participate in the study
- Having the skills to do the tests and exercises to be applied
Exclusion Criteria:
- Having a history of upper extremity injury within the past year
- Having a sensory problem that prevents participation in the study
- Have any musculoskeletal, neurological, respiratory, or cardiovascular risk factors that limit exercise
- Having a history of malignant disease
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 |
|---|---|---|
|
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Time Frame: Six month
|
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
|
Six month
|
|
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Time Frame: Six month
|
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
|
Six month
|
|
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
Time Frame: Six month
|
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
|
Six month
|
|
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
Time Frame: Six month
|
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
|
Six month
|
|
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Time Frame: Six month
|
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
|
Six month
|
|
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Time Frame: Six month
|
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
|
Six month
|
|
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
Time Frame: Six month
|
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
|
Six month
|
|
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
Time Frame: Six month
|
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method II (25⁰ Abd and 20⁰ ER)
|
Six month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Caglar Soylu, PhD, Ankara Yildirim Beyazıt University
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)
November 15, 2019
Primary Completion (Actual)
January 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 11, 2021
First Posted (Actual)
February 16, 2021
Study Record Updates
Last Update Posted (Actual)
February 16, 2021
Last Update Submitted That Met QC Criteria
February 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2019-367
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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