NCT06821165

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 6, 2025

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

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.

    Baseline

Study Arms (1)

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

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.

Elbow Flexion Measurement Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 3685114BACKGROUND
  • 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.

    PMID: 31850253BACKGROUND
  • 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.

    PMID: 6622536BACKGROUND

MeSH Terms

Conditions

Elbow Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Central Study Contacts

Yasemin ŞAHBAZ, Asst. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share