NCT04755257

Brief 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). 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 11, 2021

Last Update Submit

February 11, 2021

Conditions

Keywords

Muscle ArchitectureShoulderIsokineticRotator muscle

Outcome Measures

Primary Outcomes (8)

  • 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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    Six month

Interventions

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.

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailshealthy male subjects
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy male subjects

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

Study Officials

  • Caglar Soylu, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Çağlar Soylu (Principal Investigator)

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

November 15, 2019

Primary Completion

January 15, 2020

Study Completion

May 15, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations