NCT06474130

Brief Summary

To develop a cervical SMC VR assessment system incorporating different SMC tests and to compare cervical SMC performance using this self-developed VR assessment system in individuals with and without CNP

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

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

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

June 19, 2024

Last Update Submit

April 7, 2026

Conditions

Keywords

Sensorimotor controlVirtual RealityChronic neck Paincervical

Outcome Measures

Primary Outcomes (8)

  • Cervical Range of Motion (ROM)

    Participants will follow the instructions that appeared in the VR HMD to perform active maximal neck flexion, extension, side bending and rotation. The maximal ROM in each direction will be calculated and obtained based on the IMU sensors embedded in the HMD.

    One day

  • Joint Position Error (JPE)

    There will be a virtual target displayed in the VR HMD. Participant will be instructed to remember this position, then close their eyes and move the head away from the target center, and then return to the initial starting position. Difference between the starting position and final position in distance (mm) will be calculated.

    One day

  • Figure of Eight (FOE)

    The participant will be instructed to control the red dot moving along the path of the figure-of-eight as accurately as possible by moving their head.

    One day

  • Subjective Visual Vertical (SVV)

    A tilted white rod will be presented at different angles for 1-degree interval from 45 to 135 degrees randomly on the display as described above. The rod will be precisely controlled by using left and right arrow keys of a keyboard. Participants will be instructed to reposition the white rod so that the white rod will be positioned vertically while keeping the head and neck as still as possible.

    One day

  • Head Tile Response (HTR)

    A tilted white rod will be presented at different angles for 1-degree interval from 45 to 135 degrees randomly on the display as described above. Participants will be instructed to tilt their heads laterally so that the line will be re-positioned vertically.

    One day

  • Saccades

    Two virtual white targets at 90 degrees of visual angle positioned 0.82 m apart from the participant will be displayed in the VR HMD. Participants will be asked to shift their gaze quickly between two targets without moving their heads for 10 secs.

    One day

  • Smooth Pursuit Neck Torsion (SPNT)

    A virtual red-dot target is displayed in the VR HMD. The target will move in a horizontal plane with a sinusoidal pattern (30 degrees per second) from left to right and back 10 times with a visual angle of 40 degrees. Participants will be requested to follow the moving target with their eyes and keep their heads still.

    One day

  • Postural Sway (PS)

    Participants will be asked to follow the instructions that appeared in the VR HMD and stand still for 30 seconds in EO or EC condition and in neck neutral or neck torsion 45-degree position

    One day

Study Arms (2)

Chronic neck pain group

Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra; Neck pain persisting for 3 months and above; Average pain intensity of last pain episode was between 2 and 8 based on the numerical rating scale (NRS).

Healthy adults group

Do not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with CNP will be recruited from the affiliated hospital, local outpatient clinics, local communities and around the campus. Healthy adults will be recruited from the local communities near the university in the Tainan city.

You may qualify if:

  • For patients with chronic neck pain:
  • Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra,
  • Neck pain persisting for 3 months and above,
  • Average pain intensity of last pain episode was between 2 and 8 based on the numerical rating scale (NRS)
  • Healthy asymptomatic adults:
  • Do not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months

You may not qualify if:

  • acute or the first onset of neck pain
  • previous fracture or surgery of the spine
  • diagnosed cardiopulmonary diseases, for example, chronic obstructive pulmonary disease, pulmonary tuberculosis, asthma, chronic bronchitis, pulmonary emphysema
  • diagnosed gastrointestinal and abdominal conditions which may interfere daily activities within the past 6 months
  • medical conditions that may affect balance and study procedures (e.g. neurological diseases, vestibular disorders, malignant tumors)
  • metabolic diseases such as anemia and diabetes
  • smoking, plan to pregnant or in pregnancy
  • psychological disorders (affect questionnaire responses)
  • unable to walk independently
  • Corrected visual abnormalities or individuals unable to wear contact lenses for vision correction due to the potential interference of wearing VR head-mounted display with glasses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan, 701, Taiwan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

February 17, 2025

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations