Rotator Cuff Tear ArthropathyNCT06105398
the Effect of Core Stability on Hand Functions
An observational study of Rotator Cuff Tear Arthropathy, run by Gülçe İrem Yalçınkaya at 1 site in Turkey (Türkiye).
Trial summary
Determining the factors affecting hand function after upper limb injuries is very important for maintaining independence in daily living activities. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing rotator cuff surgery and to compare the results… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- clinical evaluation
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2023to 25 Dec 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study group: 47 patients between the ages of 40-75 Control group : 47 healthy adults between the ages of 40-75
Who may be able to join
- - Patients who have had rotator cuff repair done (at least one year ago)
- Non-rerupturants
- Those who have not suffered any other upper limb injuries after surgery
- Those who do not have any chronic diseases that can negatively affect ligament healing
- Those who do not have any spinal and lumbar region pathology
- Those who do not have lower back and back pain
- Those who do not have any neuromuscular diseases
- Those who can be cooperated
Who cannot join
- Patients who have not had rotator cuff repair
- Those who are recurrent
- Those who have suffered any other upper limb injury after surgery
- Those with any chronic diseases that can negatively affect ligament healing
- Those with any spinal and lumbar region pathology
- Those with lower back and back pain
Show all 10Show fewer
- Those who have undergone spinal surgery
- Those with any neuromuscular disease
- Those who cannot establish coperation
- Patients who did not complete the evaluations and wanted to leave voluntarily were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation Of The Effect Of Core Stability On Hand Functions In Patients Undergoing Rotator Cuff Surgery
Determining the factors affecting hand function after upper limb injuries is very important for maintaining independence in daily living activities. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing rotator cuff surgery and to compare the results with healthy patients of a similar age. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing artroscopic cuff surgery.
Read the detailed description
The shoulder joint is a joint that is open to injuries due to its wide December of movement. For this reason, it is the most important cause of upper extremity pain.The most common cause of shoulder pain is rotator cuff injuries.Rotator cuff injuries are a painful problem of the shoulder that causes movement restriction, pain and impaired functional activities. Excessive use of the shoulder occurs as a result of impaired shoulder stability, November, muscle weakness, trauma. Although the prevalence of rotator cuff ruptures increases with age, they usually start at the age of 40 and the incidence increases by 54% at the age of 60 and by 60- 80% at the age of 80. It has a prevalence ranging from 20-50% in the general population. Arthroscopic repair has found widespread use due to the reasons that the protection of the adhesion site of the deltoid November, the diagnosis and treatment of concomitant intra-articular pathologies are easier, adhesions are less common, pain is less and rehabilitation after repair is easier.Core stability is considered very important in terms of biomechanical efficiency because it optimizes force production in all kinds of physical activities, from running to throwing, and minimizes the loads placed on the joints. However, there is little clarity about exactly what the anatomical and physiological characteristics of the structures that make up core stability are. However, core stability is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimal production, transfer and control of force and movement to the terminal segment during activities. Core November muscle activity is best understood as the pre-programmed integration of regional, single-jointed and multi-jointed muscles to provide stability and November muscle activity is best understood as the pre-programmed integration of regional, single-jointed and multi-jointed muscles to produce movement. This results in the creation of proximal stability for distal mobility, a proximal-to-distal model of force generation, and interactive moments that move and protect the distal joints . Strong core stabilization minimizes the load on the vertebral column, increases the durability of the peripheral joints and also provides energy transfer to the distal segments. The relationship between core stability and limb Deceleration performance has been studied in athletes in general. However, most of the studies have focused on core stability and lower limb relationship.Evaluation of hand function and performance is important in terms of determining the person's skill level in daily life activities and demonstrating the effectiveness of rehabilitation.Hand function can be defined as the capacity of the hand for daily activities in connection with anatomical integrity, mobility, strength, sensation, coordination, age, gender, mental status, illness or trauma, and the condition of other proximal limb joints (shoulder, elbow, wrist). In order to determine which approaches are more effective in correcting the loss of function that occurs after various injuries and diseases, it is first necessary to have a good understanding of the factors that affect this performance.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- clinical evaluation
- Keywords
- Hand Function, Core Stability
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluationOther
clinical evaluation tests
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients between the ages of 40-75 who had rotator cuff repair at least one year ago at the Orthopedics and Traumatology Clinic of Pamukkale University Receives: Other: clinical evaluation | |
| Control group | healthy adults between the ages of 40-75 Receives: Other: clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand dominance test
Edinburgh Hand Preference Survey
Measured: 1 year
muscle strength test
Jamar Hand Dynamometer
Measured: 1 year
Evaluation of reaction time test
Nelson hand reaction test
Measured: 1 year
upper extremity function test
Q-DASH Survey
Measured: 1 year
hand function test
Jebsen Taylor Hand Function Test
Measured: 1 year
upper extremity balance test
Upper Extremity Y Balance Test
Measured: 1 year
core stabilization test
Core Stabilization Assessment (trunk flexor, trunk extensor endurance, side plank, double straight leg lowering)
Measured: 1 year
Pain scale
Visual Analog Scale (VAS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start25 Sep 2023
- Primary completion23 Oct 2023
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülçe İrem Yalçınkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülçe İrem Yalçınkaya, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105398
- Sponsor's protocol ID
- Pamukkale Universty
- Status last verified
- Oct 2023
- First submitted
- 7 Aug 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effect Of Core Stability On Hand Functions In Patients Undergoing Rotator Cuff Surgery
- ClinicalTrials.gov ID
- NCT06105398
- Acronym / sponsor ID
- Pamukkale Universty
- Conditions
- Rotator Cuff Tear Arthropathy
- Keywords
- Hand Function, Core Stability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Gülçe İrem YalçınkayaUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 27 Oct 2023 (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.
Determining the factors affecting hand function after upper limb injuries is very important for maintaining independence in daily living activities. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing rotator cuff surgery and to compare the results with healthy patients of a similar age. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing artroscopic cuff surgery.
Detailed description
The shoulder joint is a joint that is open to injuries due to its wide December of movement. For this reason, it is the most important cause of upper extremity pain.The most common cause of shoulder pain is rotator cuff injuries.Rotator cuff injuries are a painful problem of the shoulder that causes movement restriction, pain and impaired functional activities. Excessive use of the shoulder occurs as a result of impaired shoulder stability, November, muscle weakness, trauma. Although the prevalence of rotator cuff ruptures increases with age, they usually start at the age of 40 and the incidence increases by 54% at the age of 60 and by 60- 80% at the age of 80. It has a prevalence ranging from 20-50% in the general population. Arthroscopic repair has found widespread use due to the reasons that the protection of the adhesion site of the deltoid November, the diagnosis and treatment of concomitant intra-articular pathologies are easier, adhesions are less common, pain is less and rehabilitation after repair is easier.Core stability is considered very important in terms of biomechanical efficiency because it optimizes force production in all kinds of physical activities, from running to throwing, and minimizes the loads placed on the joints. However, there is little clarity about exactly what the anatomical and physiological characteristics of the structures that make up core stability are. However, core stability is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimal production, transfer and control of force and movement to the terminal segment during activities. Core November muscle activity is best understood as the pre-programmed integration of regional, single-jointed and multi-jointed muscles to provide stability and November muscle activity is best understood as the pre-programmed integration of regional, single-jointed and multi-jointed muscles to produce movement. This results in the creation of proximal stability for distal mobility, a proximal-to-distal model of force generation, and interactive moments that move and protect the distal joints . Strong core stabilization minimizes the load on the vertebral column, increases the durability of the peripheral joints and also provides energy transfer to the distal segments. The relationship between core stability and limb Deceleration performance has been studied in athletes in general. However, most of the studies have focused on core stability and lower limb relationship.Evaluation of hand function and performance is important in terms of determining the person's skill level in daily life activities and demonstrating the effectiveness of rehabilitation.Hand function can be defined as the capacity of the hand for daily activities in connection with anatomical integrity, mobility, strength, sensation, coordination, age, gender, mental status, illness or trauma, and the condition of other proximal limb joints (shoulder, elbow, wrist). In order to determine which approaches are more effective in correcting the loss of function that occurs after various injuries and diseases, it is first necessary to have a good understanding of the factors that affect this performance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: clinical evaluationPatients between the ages of 40-75 who had rotator cuff repair at least one year ago at the Orthopedics and Traumatology Clinic of Pamukkale University |
| Control group | – | Other: clinical evaluationhealthy adults between the ages of 40-75 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study group: 47 patients between the ages of 40-75 Control group : 47 healthy adults between the ages of 40-75
Key inclusion criteria (8 listed)
- - Patients who have had rotator cuff repair done (at least one year ago)
- Non-rerupturants
- Those who have not suffered any other upper limb injuries after surgery
- Those who do not have any chronic diseases that can negatively affect ligament healing
- Those who do not have any spinal and lumbar region pathology
Key exclusion criteria (10 listed)
- Patients who have not had rotator cuff repair
- Those who are recurrent
- Those who have suffered any other upper limb injury after surgery
- Those with any chronic diseases that can negatively affect ligament healing
- Those with any spinal and lumbar region pathology
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 |
|---|---|---|
| clinical evaluationclinical evaluation tests | Other | Control group, Study group |
Primary outcome
hand dominance test
Time frame: 1 year
Edinburgh Hand Preference Survey
muscle strength test
Time frame: 1 year
Jamar Hand Dynamometer
Evaluation of reaction time test
Time frame: 1 year
Nelson hand reaction test
upper extremity function test
Time frame: 1 year
Q-DASH Survey
hand function test
Time frame: 1 year
Jebsen Taylor Hand Function Test
upper extremity balance test
Time frame: 1 year
Upper Extremity Y Balance Test
core stabilization test
Time frame: 1 year
Core Stabilization Assessment (trunk flexor, trunk extensor endurance, side plank, double straight leg lowering)
Pain scale
Time frame: 1 year
Visual Analog Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rotator Cuff Tear Arthropathy, run by Gülçe İrem Yalçınkaya 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
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?
hand dominance test (time frame: 1 year). 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 27 Oct 2023.