AzTrials
AzTrials

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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Turkey (Türkiye)1 site
  • Pamukkale University

    Denizli

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06105398
Study groupRoleWhat they receive
Study groupPatients 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 grouphealthy 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.

  1. hand dominance test

    Edinburgh Hand Preference Survey

    Measured: 1 year

  2. muscle strength test

    Jamar Hand Dynamometer

    Measured: 1 year

  3. Evaluation of reaction time test

    Nelson hand reaction test

    Measured: 1 year

  4. upper extremity function test

    Q-DASH Survey

    Measured: 1 year

  5. hand function test

    Jebsen Taylor Hand Function Test

    Measured: 1 year

  6. upper extremity balance test

    Upper Extremity Y Balance Test

    Measured: 1 year

  7. core stabilization test

    Core Stabilization Assessment (trunk flexor, trunk extensor endurance, side plank, double straight leg lowering)

    Measured: 1 year

  8. 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.

  1. First posted27 Oct 2023
  2. Study start25 Sep 2023
  3. Primary completion23 Oct 2023
  4. Study completion25 Dec 2024 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in