Assessing the Reliability of Smooth Pursuit Across Various Neck Postures Using a Custom Ocular Motor Detection System

NCT06634576 | Completed

• 1 other identifier: KMUHIRB-F(II)-20210114
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Purpose: The assessment of ocular motor control through the manipulation of diverse sensory stimuli can facilitate the diagnosis of dizziness. However, the testing process typically encompasses a single rotational axis. This study aims to investigate the performance of ocular motor control under multi-axis neck rotation postures. To verify the data quality performance and reliability of the custom-made ocular motor features detection system, validate the consistency of system eye movement parameters, and investigate the effect of different neck plane positions on tracking performance. Methods: A total of seven healthy volunteers participated in this study. The study involved ocular motor tracking tasks in different neck positions with all seven subjects, A total of seven subjects were examined, comprising neutral neck posture, left lateral flexion posture, right lateral flexion posture, neck extension posture, neck flexion posture, left neck torsion posture, and right neck torsion posture. The study evaluated eye movement parameters in different planes, including Gain (representing pursuit speed), SPNTD (representing pursuit differences across planes), Accuracy (representing pursuit accuracy), and Latency (representing pursuit latency), as well as the reliability of these parameters. The reliability of the parameters was verified using the intraclass coefficient (ICC). Non-parametric tests (Friedman test) were used to verify the performance of ocular motor tracking in different neck positions, and post-hoc analysis (Wilcoxon sign test) was used to verify statistical differences.

Conditions

Ocular Motor Detectation; Vestibular; Cervicogenic Dizziness; Oculomotor System

Keywords

Oculomotor system; Vestibular; cervicogenic dizziness; Ocular motor detectation

Outcome Measures

Primary Outcomes (1)

• Analyzied the reliability of custom-made ocular motor detectation system

  The custom-made system would output four parameters in this study. Used Intraclass correlation coefficient (ICC) to examine the reliability of pursuit parameters.

  From enrollment to the end of research at 1 day.

Secondary Outcomes (1)

• Examine the pursuit ability in seven different neck postures.

  From enrollment to the end of treatment at 1 day

Study Arms (1)

Health population

EXPERIMENTAL

Used custom-made ocular motor system to adjust the neck postures of participants, to examine the reliability of data and compared the pursuit ability in three different neck motion planes, seven different neck postures.

Device: Smooth pursuit neck torsion test

Interventions

Smooth pursuit neck torsion test DEVICE

Used custom-made system to stimulate the procedure of smooth pursuit neck torsion test in the current study, the multiple axis motion platform can adjust the neck postures to three different neck motion planes, seven different neck postures.

Health population

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 60 years.
• No history of significant neck surgeries.
• No history of corrective eye surgery.
• No skeletal muscle injuries or pain in the upper or lower limbs.
• Free from vestibular system-related disorders and neurological symptoms.
• Participants must avoid food and drink for 3 hours before the experiment.
• Participants should have 8 hours of sleep the night before the experiment.

You may not qualify if:

• Any participant who has undergone vision correction surgery in the last year.
• Any participant who has experienced significant head or neck trauma in the past year.
• Any participant with a history of vestibular system disorders or neurological symptoms.
• Participants who have used medications or alcohol for an extended period.
• Participants with abnormal pain in any part of the torso.
• Individuals suffering from claustrophobia.

Sponsors & Collaborators

• Kaohsiung Medical University: lead
• National Health Research Institutes, Taiwan: collaborator
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Sanmin District, 807378, Taiwan

Location

Study Officials

• Guo Lan-Yuen Guo, Lan-Yuen, Professor, Phd

  Kaohsiung Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In research protocol, all neck postures were randomized, and did eye tracker recalibration before each task.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All for health populations. Inclusion criterias following: 1. Age between 20 and 60 years. 2. No history of significant neck surgeries. 3. No history of corrective eye surgery. 4. No skeletal muscle injuries or pain in the upper or lower limbs. 5. Free from vestibular system-related disorders and neurological symptoms. 6. Participants must avoid food and drink for 3 hours before the experiment. 7. Participants should have 8 hours of sleep the night before the experiment. Exclusion criterias following: 1. Any participant who has undergone vision correction surgery in the last year. 2. Any participant who has experienced significant head or neck trauma in the past year. 3. Any participant with a history of vestibular system disorders or neurological symptoms. 4. Participants who have used medications or alcohol for an extended period. 5. Participants with abnormal pain in any part of the torso. 6. Individuals suffering from claustrophobia.

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 10, 2024
• Study Start: April 3, 2024
• Primary Completion: April 24, 2024
• Study Completion: June 30, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results.

Locations

TW (1)