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Not yet recruitingNCT06821165Updated Feb 25, 2025

Validity and Reliability of Dr. Goniometer in Elbow Flexion

An observational study in Elbow Joint Injuries, sponsored by University of Beykent. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by University of Beykent · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Elbow Joint Injuries
03

In context

Lead sponsor

University of Beykent is the lead sponsor of 54 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Dr. Goniometer Application

Interventions

  • OtherDr. Goniometer Application

    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.

06

What researchers measure

Primary outcomes

  1. Validity and Reliability of Dr. Goniometer in Elbow Flexion Measurements

    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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867. PubMed 3685114 ↗
  • Jee H, Park J. Comparative Analyses of the Dominant and Non-Dominant Upper Limbs during the Abduction and Adduction Motions. Iran J Public Health. 2019 Oct;48(10):1768-1776. PubMed 31850253 ↗
  • Rothstein JM, Miller PJ, Roettger RF. Goniometric reliability in a clinical setting. Elbow and knee measurements. Phys Ther. 1983 Oct;63(10):1611-5. doi: 10.1093/ptj/63.10.1611. PubMed 6622536 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06821165
Lead sponsor
University of Beykent
Responsible party
Yasemin Şahbaz (Assistant Professor, University of Beykent) — Principal investigator
First posted
Feb 11, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Feb 25, 2025

Study contacts

Yasemin ŞAHBAZ, Asst. Prof.
Contact
yaseminsahbaz@beykent.edu.tr
05455649695

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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