- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06821165
Validity and Reliability of Dr. Goniometer in Elbow Flexion
Validity and Reliability Analysis of the Dr. Goniometer Application in Elbow Flexion Measurements
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yasemin ŞAHBAZ, Asst. Prof.
- Phone Number: 05455649695
- Email: yaseminsahbaz@beykent.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Elbow Joint Injuries
-
Assaf-Harofeh Medical CenterCompletedElbow Dislocation | Heterotopic OssificationIsrael
-
Western University, CanadaLawson Health Research InstituteNot yet recruitingElbow Fracture | Elbow Injury | Elbow Arthritis
-
Region ÖstergötlandKalmar County Council; Jönköping county councilUnknownElbow Fracture | Early Mobilization | Elbow Stiffnes
-
University of VermontRecruitingLateral Elbow Tendinopathy (Tennis Elbow)United States
-
Vanderbilt UniversityTerminatedElbow Fracture | Upper Extremity Fracture | Fractures, Comminuted | Elbow Dislocation | Upper Extremity DislocationUnited States
-
Central Hospital, Nancy, FranceActive, not recruitingElbow Fracture | Elbow Arthropathy | Elbow OsteoarthritisFrance
-
Marmara UniversityRecruitingLateral Epicondylitis | Lateral Elbow Tendinopathy (Tennis Elbow)Turkey (Türkiye)
-
Marmara UniversityRecruitingLateral Elbow Tendinopathy (Tennis Elbow)Turkey (Türkiye)
-
Hospital Universitario La PazActive, not recruitingElbow Fracture | Elbow Arthropathy | Elbow Injury | Elbow Dislocation | Elbow Fractures Involving a Combination of Fractures of the Radius and UlnSpain
-
Haydarpasa Numune Training and Research HospitalNot yet recruiting
Clinical Trials on Dr. Goniometer Application
-
Istanbul Medeniyet UniversityCompletedShoulder PainTurkey
-
Aliaa Rehan YoussefCompleted
-
The Cleveland ClinicCompleted
-
Riphah International UniversityCompleted
-
Cairo UniversityCompleted
-
European University CyprusBrunel UniversityNot yet recruitingCervical Spine Motion Assessment in Healthy AdultsCyprus
-
Duramed ResearchCompletedEndometriosisUnited States
-
Duramed ResearchCompletedStudy to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive BladderUrinary IncontinenceUnited States, Canada
-
LivaNovaCompletedAssess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.Italy, France, Spain, United States, Germany, United Kingdom
-
LivaNovaCompletedTachycardiaFrance, Germany, Portugal, Italy, Canada, United States, Belgium, Netherlands, United Kingdom