Validity and Reliability of Dr. Goniometer in Elbow Flexion

February 21, 2025 updated by: Yasemin Şahbaz, University of Beykent

Validity and Reliability Analysis of the Dr. Goniometer Application in Elbow Flexion Measurements

This study aims to evaluate the validity and reliability of the Dr. Goniometer application for measuring elbow flexion by comparing it with a manual goniometer. Conducted at Beykent University, the study will include 60 participants without upper extremity issues. Measurements will be taken on the dominant arm using both a manual goniometer and Dr. Goniometer, each repeated twice. Dr. Goniometer measurements will be performed twice by two different evaluators. Validity will be assessed using the Pearson correlation coefficient, while reliability will be evaluated with ICC and SEM. Measurement differences will be analyzed using a paired t-test. The results will contribute to determining the clinical applicability of the Dr. Goniometer application.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

This study is designed to assess both the validity and reliability of the Dr. Goniometer application for measuring elbow flexion. To do this, the study will compare the measurements taken using the Dr. Goniometer with those obtained using a manual goniometer, which is the standard tool typically used for such measurements.

Study Design and Participants:

The research will be conducted at Beykent University and will involve 60 participants. These individuals will be healthy and will not have any upper extremity issues (meaning they do not have any conditions affecting their arms).

The dominant arm of each participant will be used for measurement purposes. The dominant arm is the arm most commonly used for tasks like writing or eating.

Measurement Process:

Each participant's elbow flexion will be measured using both the manual goniometer and the Dr. Goniometer application.

The measurements will be taken twice using each tool, ensuring that there is a repetition for both the Dr. Goniometer and the manual goniometer.

Additionally, the Dr. Goniometer measurements will be performed twice by two different evaluators. This step is included to ensure that the measurements are consistent and to assess inter-rater reliability (the degree to which two different evaluators get the same results).

Statistical Analysis:

Validity will be assessed by calculating the Pearson correlation coefficient. This coefficient will measure the degree to which the measurements from the Dr. Goniometer correspond to the measurements from the manual goniometer. A high correlation would indicate that the Dr. Goniometer is valid and produces results similar to the established manual goniometer.

Reliability will be evaluated using two methods:

Intraclass Correlation Coefficient (ICC): This will assess the consistency or agreement of measurements taken with the same tool (e.g., using the Dr. Goniometer application multiple times by the same or different evaluators).

Standard Error of Measurement (SEM): This will measure the precision of the measurements and help understand the typical error expected in the measurements.

Measurement differences between the two tools (Dr. Goniometer and manual goniometer) will be analyzed using a paired t-test. This test will help determine whether there are any statistically significant differences between the measurements obtained from the two devices. If there is a significant difference, it could suggest that one tool is more accurate than the other or that they produce inconsistent results.

Expected Outcome:

The study will aim to determine whether the Dr. Goniometer application is clinically applicable. By assessing both its validity (how well it measures what it is intended to measure) and its reliability (how consistent and precise it is), the results will provide insight into whether this mobile application can be used effectively in clinical settings as a tool for measuring elbow flexion. If the application is found to be both valid and reliable, it could offer a convenient and accessible alternative to the traditional manual goniometer.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of healthy adults aged 18-65 who have no history of musculoskeletal, neurological, or orthopedic disorders affecting the upper extremity. Participants will be recruited voluntarily from the general population and must be able to provide informed consent and follow verbal instructions.

Description

Inclusion Criteria:

  • Aged between 18 and 65 years
  • No history of musculoskeletal, neurological, or orthopedic conditions
  • Voluntary participation

Exclusion Criteria:

  • History of musculoskeletal, neurological, or orthopedic disorders affecting the upper extremity.
  • Previous upper extremity trauma, surgery, or chronic pain limiting range of motion.
  • Inability to provide informed consent or follow verbal instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elbow Flexion Measurement Group
Participants in this group will undergo elbow flexion range of motion (ROM) assessment using both a manual goniometer and the Dr. Goniometer application. Each participant's measurements will be taken twice. The measurements will be conducted twice by two different evaluators, and the average values will be analyzed to determine the validity and reliability of the Dr. Goniometer application compared to the manual goniometer.
The Dr. Goniometer application is a digital tool used for measuring elbow flexion range of motion (ROM). In this study, participants' elbow flexion ROM will be assessed using both the Dr. Goniometer application and a manual goniometer. Measurements will be taken twice by two different raters to evaluate the validity and reliability of the digital application compared to the manual goniometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity and Reliability of Dr. Goniometer in Elbow Flexion Measurements
Time Frame: Baseline
Comparison of elbow flexion range of motion measurements obtained using the Dr. Goniometer application and a universal goniometer to assess validity and reliability. Measurements will be taken by three independent raters, and intra-rater and inter-rater reliability will be analyzed using ICC and SEM. Pearson correlation will be used to determine validity.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UBeykent-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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