Muscle ArchitectureNCT04755257
Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles
An observational study of Muscle Architecture and Shoulder, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Muscle Architecture, Shoulder, Isokinetic
- What is being tested?
- Isokinetic test
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Adult
Study population: healthy male subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Etlik, 06010
About this study
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
- Conditions
- Muscle Architecture, Shoulder, Isokinetic, Rotator Muscle
- Being tested
- Isokinetic test
- Keywords
- Muscle Architecture, Shoulder, Isokinetic, Rotator muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic testDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
concentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Measured: Six month
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
concentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Measured: 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)
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)
Measured: 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)
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)
Measured: Six month
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
eccentric shoulder internal rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Measured: Six month
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
eccentric shoulder external rotation peak torque and peak torque/weight at the angular velocity of 60˚/s in Method I (scapular position)
Measured: 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)
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)
Measured: 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)
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)
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Nov 2019
- Primary completion15 Jan 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle ArchitectureStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caglar soylu, Ankara Yildirim Beyazıt University
- Investigators
- Caglar Soylu, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755257
- Sponsor's protocol ID
- 2019-367
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles
- ClinicalTrials.gov ID
- NCT04755257
- Acronym / sponsor ID
- 2019-367
- Conditions
- Muscle Architecture, Shoulder, Isokinetic, Rotator Muscle
- Keywords
- Muscle Architecture, Shoulder, Isokinetic, Rotator muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- healthy male subjects
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic testUsing 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. | Device | – |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caglar Soylu, PhD principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Architecture and Shoulder, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.