Elbow Joint InjuriesNCT06821165
Validity and Reliability of Dr. Goniometer in Elbow Flexion
An observational study of Elbow Joint Injuries, run by University of Beykent.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elbow Joint Injuries
- What is being tested?
- Dr. Goniometer Application
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged between 18 and 65 years
- No history of musculoskeletal, neurological, or orthopedic conditions
- Voluntary participation
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Elbow Joint Injuries
- Being tested
- Dr. Goniometer Application
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr. Goniometer ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dr. Goniometer Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Elbow Joint InjuriesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821165
- Sponsor's protocol ID
- UBeykent-12
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 3685114Jee 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 31850253Rothstein 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Analysis of the Dr. Goniometer Application in Elbow Flexion Measurements
- ClinicalTrials.gov ID
- NCT06821165
- Acronym / sponsor ID
- UBeykent-12
- Conditions
- Elbow Joint Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elbow Flexion Measurement Group | – | Other: Dr. Goniometer ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years
- No history of musculoskeletal, neurological, or orthopedic conditions
- Voluntary participation
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Dr. Goniometer ApplicationThe 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. | Other | Elbow Flexion Measurement Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 3685114Gajdosik 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.
- Background: PubMed 31850253Jee 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.
- Background: PubMed 6622536Rothstein 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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Joint Injuries, run by University of Beykent.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin ŞAHBAZ, Asst. Prof. (05455649695, yaseminsahbaz@beykent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability of Dr. Goniometer in Elbow Flexion Measurements (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821165, which also lists 3 linked publications.
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 25 Feb 2025.