NCT06105398

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

28 days

First QC Date

August 7, 2023

Last Update Submit

October 23, 2023

Conditions

Keywords

Hand Function, Core Stability

Outcome Measures

Primary Outcomes (8)

  • hand dominance test

    Edinburgh Hand Preference Survey

    1 year

  • muscle strength test

    Jamar Hand Dynamometer

    1 year

  • Evaluation of reaction time test

    Nelson hand reaction test

    1 year

  • upper extremity function test

    Q-DASH Survey

    1 year

  • hand function test

    Jebsen Taylor Hand Function Test

    1 year

  • upper extremity balance test

    Upper Extremity Y Balance Test

    1 year

  • core stabilization test

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

    1 year

  • Pain scale

    Visual Analog Scale (VAS)

    1 year

Study Arms (2)

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

Other: clinical evaluation

Control group

healthy adults between the ages of 40-75

Other: clinical evaluation

Interventions

clinical evaluation tests

Control groupStudy group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study group: 47 patients between the ages of 40-75 Control group : 47 healthy adults between the ages of 40-75

You may qualify if:

  • \- 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2023

First Posted

October 27, 2023

Study Start

September 25, 2023

Primary Completion

October 23, 2023

Study Completion

December 25, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations