NCT07089628

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

July 21, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Core StabilityCore StabilizationReaction timeHand- Eye CoordinationPainFunction

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (4)

  • Reaction Time

    Baseline

  • Hand-Wall Toss Test

    Baseline

  • Visual Analogue Scale

    Baseline

  • Shoulder Pain and Disability Index

    Baseline

Study Arms (2)

Rotator Cuff Lesion Group

This group will consist of individuals with rotator cuff lesions. The assessments described will be conducted on these participants.

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.

Other: Assessment

Interventions

There is no intervention in this study. Participants will only undergo assessments.

Control GroupRotator Cuff Lesion Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Zeynep Hazar, Prof.

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 28, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations