Core StabilityNCT07089628
Investigation of the Relationship Between Core Stability and Reaction Time, Hand-Eye Coordination, Pain, and Functional Status in Individuals With Rotator Cuff Lesions
An observational study of Core Stability and Core Stabilization, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
Rotator cuff lesions are among the most common problems within musculoskeletal disorders. The prevalence of these lesions increases with age, and they encompass a wide spectrum of various injuries and pathological conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Core Stability, Core Stabilization, Reaction Time
- What is being tested?
- Assessment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: "Rotator cuff lesions are among the most common problems within musculoskeletal disorders. The prevalence of these lesions increases with age, and they encompass a wide spectrum of various injuries and pathological conditions. The literature frequently reports that these lesions often result in pain, reduced functional capacity, and a decline in quality of life. Although some of these lesions are traumatic in nature, the majority of rotator cuff issues are degenerative due to age-related changes in tendon structure.
Who may be able to join
- Having a diagnosis of a rotator cuff lesion confirmed by a physician
- Having no history of any surgical procedure related to the shoulder
- Experiencing activity-related pain scored as 3 or higher on the Visual Analog Scale
Who cannot join
- Presence of systemic inflammatory diseases
- Pregnancy
- Presence of mental health disorders
- Individuals with communication difficulties
- Presence of other significant shoulder pathologies such as dislocation, fracture, arthritis, or frozen shoulder
- All of these criteria apply to the group with rotator cuff lesions. The other group consists of healthy, asymptomatic individuals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Gazi University Gazi University, 0 312 216 26 21, sbf.ftr@gmail.com
About this study
Rotator cuff lesions are among the most common problems within musculoskeletal disorders. The prevalence of these lesions increases with age, and they encompass a wide spectrum of various injuries and pathological conditions. The literature frequently reports that such lesions often lead to pain, decreased functional capacity, and a reduction in quality of life. Although some of these lesions are traumatic in origin, the majority of rotator cuff problems are degenerative due to age-related changes in tendon structure.
Recent scientific studies have indicated that core stability may be a significant factor in such musculoskeletal problems. Adequate core stabilization not only minimizes the load on the vertebral column but also enhances the strength and endurance of peripheral joints and facilitates the transfer of energy to distal segments. Given that rotator cuff lesions can adversely affect upper extremity functions and potentially result in reduced core stability, we hypothesize that they may negatively influence reaction time and hand-eye coordination, which are essential for the effective execution of motor tasks.
To date, no studies have been identified in the literature investigating the relationship between core stability and reaction time or hand-eye coordination in individuals with rotator cuff lesions. In light of this information, the aim of our planned study is to examine the relationship between core stability and reaction time, hand-eye coordination, pain, and functional status in individuals with rotator cuff lesions and to compare these findings with asymptomatic individuals.
- Conditions
- Core Stability, Core Stabilization, Reaction Time, Pain, Function
- Being tested
- Assessment
- Keywords
- Core Stability, Core Stabilization, Reaction time, Hand- Eye Coordination, Pain, Function
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
There is no intervention in this study. Participants will only undergo assessments.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Lesion Group | This group will consist of individuals with rotator cuff lesions. The assessments described will be conducted on these participants. Receives: Other: Assessment | |
| Control Group | This group will include asymptomatic control participants, consisting of patient relatives, university staff, and students who have no shoulder problems and are matched in terms of age, sex, and educational level. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified "Biering-Sorensen" test
Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds.
Measured: Baseline
Trunk flexors endurance test
Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds.
Measured: Baseline
Lateral bridge test
Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds.
Measured: Baseline
Prone bridge test
Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds.
Measured: Baseline
Modified "Push-ups" test
Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded.
Measured: Baseline
Sit-ups test
Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded.
Measured: Baseline
Secondary outcomes (4)
Reaction Time
In this study, the BlazePod system will be used to measure reaction time. BlazePod is a mobile application-supported system that records response time to visual stimuli with millisecond precision through LED light pods. Prior to the assessment, a pre-test will be conducted to allow participants to adapt to the evaluation process. The right and left sides will be assessed separately. During a 30-second period, the number of extinguished LEDs, the average time to deactivate each LED (in milliseconds), and the number of missed LEDs-defined as those that automatically turn off after the designated waiting period-will be recorded.
Measured: Baseline
Hand-Wall Toss Test
Hand-eye coordination will be assessed using the Hand-Wall Toss Test. During the test, participants will be instructed to stand 2 meters away from the wall and throw a tennis ball at the wall with their right hand, catching it with their left hand, and then alternate hands, continuing this sequence for 30 seconds. The total number of successful wall tosses and catches performed without dropping the ball will be recorded.
Measured: Baseline
Visual Analogue Scale
It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10) higher scores indicate more pain.
Measured: Baseline
Shoulder Pain and Disability Index
Shoulder function will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of two sections-pain and disability-with a total of 13 items. Each item is scored on a scale from 0 to 10, and the results are calculated as a percentage. The total score ranges from 0 to 100, with higher scores indicating worse shoulder functional status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core StabilityStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Eren Ozen, Bandırma Onyedi Eylül University
- Investigators
- Zeynep Hazar, Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089628
- Sponsor's protocol ID
- 2025 - 985
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Stability and Reaction Time, Hand-Eye Coordination, Pain, and Functional Status in Individuals With Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT07089628
- Acronym / sponsor ID
- 2025 - 985
- Conditions
- Core Stability, Core Stabilization, Reaction Time, Pain, Function
- Keywords
- Core Stability, Core Stabilization, Reaction time, Hand- Eye Coordination, Pain, Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
Rotator cuff lesions are among the most common problems within musculoskeletal disorders. The prevalence of these lesions increases with age, and they encompass a wide spectrum of various injuries and pathological conditions. The literature frequently reports that such lesions often lead to pain, decreased functional capacity, and a reduction in quality of life. Although some of these lesions are traumatic in origin, the majority of rotator cuff problems are degenerative due to age-related changes in tendon structure.
Recent scientific studies have indicated that core stability may be a significant factor in such musculoskeletal problems. Adequate core stabilization not only minimizes the load on the vertebral column but also enhances the strength and endurance of peripheral joints and facilitates the transfer of energy to distal segments. Given that rotator cuff lesions can adversely affect upper extremity functions and potentially result in reduced core stability, we hypothesize that they may negatively influence reaction time and hand-eye coordination, which are essential for the effective execution of motor tasks.
To date, no studies have been identified in the literature investigating the relationship between core stability and reaction time or hand-eye coordination in individuals with rotator cuff lesions. In light of this information, the aim of our planned study is to examine the relationship between core stability and reaction time, hand-eye coordination, pain, and functional status in individuals with rotator cuff lesions and to compare these findings with asymptomatic individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Lesion Group | – | Other: AssessmentThis group will consist of individuals with rotator cuff lesions. The assessments described will be conducted on these participants. |
| Control Group | – | Other: AssessmentThis group will include asymptomatic control participants, consisting of patient relatives, university staff, and students who have no shoulder problems and are matched in terms of age, sex, and educational level. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- "Rotator cuff lesions are among the most common problems within musculoskeletal disorders. The prevalence of these lesions increases with age, and they encompass a wide spectrum of various injuries and pathological conditions. The literature frequently reports that these lesions often result in pain, reduced functional capacity, and a decline in quality of life. Although some of these lesions are traumatic in nature, the majority of rotator cuff issues are degenerative due to age-related changes in tendon structure.
Key inclusion criteria (3 listed)
- Having a diagnosis of a rotator cuff lesion confirmed by a physician
- Having no history of any surgical procedure related to the shoulder
- Experiencing activity-related pain scored as 3 or higher on the Visual Analog Scale
Key exclusion criteria (6 listed)
- Presence of systemic inflammatory diseases
- Pregnancy
- Presence of mental health disorders
- Individuals with communication difficulties
- Presence of other significant shoulder pathologies such as dislocation, fracture, arthritis, or frozen shoulder
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 |
|---|---|---|
| AssessmentThere is no intervention in this study. Participants will only undergo assessments. | Other | Control Group, Rotator Cuff Lesion Group |
Primary outcome
Modified "Biering-Sorensen" test
Time frame: Baseline
Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds.
Trunk flexors endurance test
Time frame: Baseline
Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds.
Lateral bridge test
Time frame: Baseline
Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds.
Prone bridge test
Time frame: Baseline
Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds.
Modified "Push-ups" test
Time frame: Baseline
Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded.
Sit-ups test
Time frame: Baseline
Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded.
4 secondary outcomes
Reaction Time
Time frame: Baseline
Hand-Wall Toss Test
Time frame: Baseline
Visual Analogue Scale
Time frame: Baseline
Shoulder Pain and Disability Index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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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.
Zeynep Hazar, Prof. study director
Gazi 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 Core Stability and Core Stabilization, run by Bandırma Onyedi Eylül 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eren Özen (+90 266 606 4598, fzterenozen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified "Biering-Sorensen" test (time frame: Baseline). The study lists 6 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 18 Sep 2025.