NCT07181798

Brief Summary

This observational study evaluates cervical proprioception using a computer vision-based system developed with OpenCV and MediaPipe. Healthy adults will perform a series of head movements while their nose tip is tracked by a camera. The primary objective is to assess the accuracy of neck position and movement perception. Data will be analyzed to determine the reliability of the tracking system. The study is non-invasive, involves no interventions, and poses minimal risk to participants. Findings may support the development of accessible diagnostic tools for clinical and research applications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

May 18, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

ProprioceptionComputer-Assisted Image Interpretation

Outcome Measures

Primary Outcomes (4)

  • Cervical Joint Position Sense (Head Relocation Error)

    With the help of algorithms, the initial position of the participant's nose tip on the screen will be recorded. Following flexion, extension, or rotation movements, the final position will be obtained, and the difference between the initial and final positions will be calculated in pixels and reported as the error score. While the primary output will be in pixels, this difference can also be expressed in degrees with the necessary conversions. Rotational movements performed during the measurement will be simultaneously recorded using the CROM device, and the values from the screen will be compared with those from the CROM to assess criterion validity, which provides the error magnitude directly in degrees. Measurements performed on the same group at two different time points will be analyzed using the Intraclass Correlation Coefficient (ICC), the Standard Error of Measurement (SEM), and Bland-Altman methods.

    The test will be repeated at 1-hour intervals.

  • Cervical Movement Sense - Patterned Tracking

    During the test, an F8 or ZZ shaped pattern will be displayed on the screen, and the participant will trace the pattern starting from the center using their nose tip. The algorithm will track the nose tip's position in each camera frame throughout the test: if the nose tip remains within the shape, the error score will be 0; if it moves outside, the distance to the nearest point of the shape will be calculated in pixels and recorded as the instantaneous error score. At the end of the test, all instantaneous error scores will be summed to obtain the total error score. The start and finish times of the test will also be recorded to determine the total test duration. Total error scores from measurements performed on the same group at different time points will be analyzed using the Intraclass Correlation Coefficient (ICC), the Standard Error of Measurement (SEM), and Bland-Altman methods.

    The test will be repeated at 1-hour intervals.

  • Cervical Movement Sense - Target Tracking:

    During the test, a rectangle will appear on the screen and move at a constant speed along the ZZ or F8 paths. The participant will attempt to keep their nose tip inside this moving rectangle. Since the speed is fixed, the test duration is the same for all participants. Scoring Methods Time-Based Score: The total time the nose tip remains inside the rectangle is divided by the total test duration. The resulting ratio ranges from 0 to 1: 1 → Best score (nose tip always inside) 0 → Worst score (nose tip never inside) Distance-Based Score: For each frame, the algorithm calculates the distance from the nose tip to the rectangle: Inside = 0 Outside = distance in pixels to the nearest edge At the end, all distances are summed to obtain the total deviation score. Both scores from measurements performed on the same group at different time points will be analyzed using the Intraclass Correlation Coefficient (ICC), the Standard Error of Measurement (SEM), and Bland-Altman methods.

    The test will be repeated at 1-week intervals.

  • Sensorimotor Control Assessment

    The test duration is 60 seconds. During this time, individual points will appear on the screen at random locations. The participant's task is to move their nose tip over these points. When the nose tip correctly reaches a point: The point will disappear, A new point will appear at a different location on the screen. At the end of the test, the number of points the participant successfully matched with their nose tip within the 60 seconds will be counted, and this value will be recorded as the test score. The test score obtained from measurements performed on the same group at different time points will be analyzed using the Intraclass Correlation Coefficient (ICC), the Standard Error of Measurement (SEM), and Bland-Altman methods.

    The test will be repeated at 1-hour intervals.

Study Arms (1)

Healthy Volunteer Cohort

A single cohort of 74 healthy adult volunteers will undergo an observational test-retest reliability study of four cervical proprioception assessments using computer-vision tracking. No medical interventions will be administered. Two distinct assessment protocols control for learning effects and follow literature-based retest intervals: Protocol A (n=37): Cervical Movement Sense Target Tracking at baseline and again after one week to assess longer-term reliability. Protocol B (n=37): Head Relocation Test in 32 participants at baseline and again after one hour. Cervical Movement Sense Patterned Tracking and Cervical Proprioceptive Function Test in all 37 participants at baseline and again after one hour to minimize short-term learning effects. Separate participant groups prevent cross-test learning, and retest intervals (1 hour vs. 1 week) align with prior studies.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of healthy adult volunteers aged 18 years and older, without any history of neck pain, spinal disorders, or other conditions affecting cervical mobility. Participants will be recruited from the general population.

You may qualify if:

  • Healthy individuals over 18 years of age
  • No neck pain

You may not qualify if:

  • Neck or spinal symptoms
  • History of cervical/spinal trauma or surgery
  • Chronic conditions affecting mobility
  • Visual or vestibular impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nevşehir Hacı Bektaş Veli University

Nevşehir, Kozakli, 50600, Turkey (Türkiye)

Location

Related Publications (14)

  • Zou GY. Sample size formulas for estimating intraclass correlation coefficients with precision and assurance. Stat Med. 2012 Dec 20;31(29):3972-81. doi: 10.1002/sim.5466. Epub 2012 Jul 4.

    PMID: 22764084BACKGROUND
  • Mondal D, Vanbelle S, Cassese A, Candel MJ. Review of sample size determination methods for the intraclass correlation coefficient in the one-way analysis of variance model. Stat Methods Med Res. 2024 Mar;33(3):532-553. doi: 10.1177/09622802231224657. Epub 2024 Feb 6.

    PMID: 38320802BACKGROUND
  • Basteris A, Pedler A, Sterling M. Evaluating the neck joint position sense error with a standard computer and a webcam. Man Ther. 2016 Dec;26:231-234. doi: 10.1016/j.math.2016.04.008. Epub 2016 Apr 23.

    PMID: 27161883BACKGROUND
  • Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.

    PMID: 33464539BACKGROUND
  • Sarig-Bahat H, Weiss PL, Laufer Y. Cervical motion assessment using virtual reality. Spine (Phila Pa 1976). 2009 May 1;34(10):1018-24. doi: 10.1097/BRS.0b013e31819b3254.

    PMID: 19404177BACKGROUND
  • Pinsault N, Fleury A, Virone G, Bouvier B, Vaillant J, Vuillerme N. Test-retest reliability of cervicocephalic relocation test to neutral head position. Physiother Theory Pract. 2008 Sep-Oct;24(5):380-91. doi: 10.1080/09593980701884824.

    PMID: 18821444BACKGROUND
  • Strimpakos N, Sakellari V, Gioftsos G, Kapreli E, Oldham J. Cervical joint position sense: an intra- and inter-examiner reliability study. Gait Posture. 2006 Jan;23(1):22-31. doi: 10.1016/j.gaitpost.2004.11.019.

    PMID: 16311191BACKGROUND
  • Werner IM, Ernst MJ, Treleaven J, Crawford RJ. Intra and interrater reliability and clinical feasibility of a simple measure of cervical movement sense in patients with neck pain. BMC Musculoskelet Disord. 2018 Oct 5;19(1):358. doi: 10.1186/s12891-018-2287-0.

    PMID: 30290759BACKGROUND
  • Kristjansson E, Oddsdottir GL. "The Fly": a new clinical assessment and treatment method for deficits of movement control in the cervical spine: reliability and validity. Spine (Phila Pa 1976). 2010 Nov 1;35(23):E1298-305. doi: 10.1097/BRS.0b013e3181e7fc0a.

    PMID: 20975484BACKGROUND
  • Kristjansson E, Hardardottir L, Asmundardottir M, Gudmundsson K. A new clinical test for cervicocephalic kinesthetic sensibility: "the fly". Arch Phys Med Rehabil. 2004 Mar;85(3):490-5. doi: 10.1016/s0003-9993(03)00619-1.

    PMID: 15031839BACKGROUND
  • Hage R, Ancenay E. Identification of a relationship between cervical spine function and rotational movement control. Ann Phys Rehabil Med. 2009 Nov;52(9):653-67. doi: 10.1016/j.rehab.2009.04.003. Epub 2009 Sep 10. English, French.

    PMID: 19783494BACKGROUND
  • Goncalves C, Silva AG. Reliability, measurement error and construct validity of four proprioceptive tests in patients with chronic idiopathic neck pain. Musculoskelet Sci Pract. 2019 Oct;43:103-109. doi: 10.1016/j.msksp.2019.07.010. Epub 2019 Jul 28.

    PMID: 31376618BACKGROUND
  • English DJ, Zacharias A, Green RA, Weerakkody N. Reliability of Cervicocephalic Proprioception Assessment: A Systematic Review. J Manipulative Physiol Ther. 2022 Jun;45(5):346-357. doi: 10.1016/j.jmpt.2022.08.005. Epub 2022 Oct 19.

    PMID: 36270904BACKGROUND
  • Sarig Bahat H, Sprecher E, Sela I, Treleaven J. Neck motion kinematics: an inter-tester reliability study using an interactive neck VR assessment in asymptomatic individuals. Eur Spine J. 2016 Jul;25(7):2139-48. doi: 10.1007/s00586-016-4388-5. Epub 2016 Jan 30.

    PMID: 26831536BACKGROUND

Study Officials

  • ismail Saraçoğlu, Associate Professor

    Kütahya University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa GÜVEN, Master of Science

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and PhD Student, Principal Investigator

Study Record Dates

First Submitted

May 18, 2025

First Posted

September 18, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations