New camera-based instrument to measure neck movement: its validity and sex differences in healthy adults
| ISRCTN | ISRCTN10681217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10681217 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | No. 2021-00020-3 |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City |
| Funder | Korea International Cooperation Agency |
- Submission date
- 12/08/2024
- Registration date
- 05/09/2024
- Last edited
- 28/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Neck pain is a common musculoskeletal problem that can limit daily activities and cause substantial healthcare costs. Accurate measurement of neck motion is essential for diagnosis and rehabilitation. This study aimed to evaluate RomIX, a new photogrammetric instrument developed by the research team to measure cervical spine motion objectively and automatically. The study examined how reliable and valid RomIX is compared with the standard manual goniometer and also explored differences in neck mobility between male and female.
Who can participate?
Healthy adults aged 18 years or older with no history of neck or shoulder disorders, no pain (VAS = 0), and minimal neck disability (NDI ≤ 4).
What does the study involve?
Participants stood in the RomIX system and performed six active neck movements: flexion, extension, right and left side bending, and right and left rotation. Each movement was held for five seconds. The same participants were also measured using a manual digital goniometer by two independent clinicians. The results from both methods were compared to test RomIX’s reliability and validity. A larger group of 480 asymptomatic adults was assessed using RomIX to establish normative reference data and investigate sex-based differences in cervical motion.
What are the possible benefits and risks of participating?
Participants contributed to validating a new instrument that may help clinicians assess neck function more accurately and efficiently. The procedure was non-invasive and safe, with no adverse effects reported. RomIX may provide a faster, marker-free, and more objective method for cervical motion assessment in clinical and rehabilitation settings.
Where is the study run from?
Ho Chi Minh City Hospital for Rehabilitation – Occupational Diseases, Vietnam
When is the study starting and how long is it expected to run for?
May 2023 to September 2024
Who is funding the study?
Korea International Cooperation Agency (KOICA) under the project “Education and Research Capacity Building Project at University of Medicine and Pharmacy at Ho Chi Minh City” (Project No. 2021-00020-3).
Who is the main contact?
Dr Nguyen Huu Duc Minh, MSc, MD (University of Medicine and Pharmacy at Ho Chi Minh City), nhdminh@ump.edu.vn
Contact information
Public, Scientific, Principal investigator
145 Nhat Tao Street, Ward 8, District 10
Ho Chi Minh City
700910
Viet Nam
 ORCID ID |
0009-0000-6185-9554 |
|---|---|
| Phone | +84 983276267 |
| nhdminh@ump.edu.vn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional observational clinimetric study" |
| Secondary study design | Cross sectional study |
| Participant information sheet | 45926_PIS.pdf |
| Scientific title | Novel photogrammetric instrument to measure cervical spine range of motion: test-retest reliability, construct validity, and sex-based assessment through a cross-sectional study on asymptomatic adults |
| Study objectives | Current Study objectives as of 27/10/2025: To examine test-retest reliability, construct validity, and measurement error of RomIX, a photogrammetric instrument developed by the authors, to measure active cervical spine range of motion (CROM) compared to manual goniometry. _____ Previous Study objectives: This study aims to examine the reliability and validity of the RomIX, a photogrammetric scanner instrument, to measure cervical range of motion (ROM) compared with manual goniometry |
| Ethics approval(s) |
1. Approved 27/07/2023, Ethics committee of University of Medicine and Pharmacy at Ho Chi Minh City (217 Hong Bang Street, Ward 11, District 5, Ho Chi Minh City, 748000, Viet Nam; +84 (0)2838558411; hanhchinh@ump.edu.vn), ref: No. 704/HDDD-DHYD 2. Approved 27/07/2023, Ethics committee of Ho Chi Minh City Hospital for Rehabilitation – Occupational Diseases (313 Au Duong Lan Street, Ward 2, District 8, Ho Chi Minh City, 751000, Viet Nam; +84 (0)2838569147; bvphcn.syt@tphcm.gov.vn), ref: No. 16/HDDD-BVPHCN-DTBNN |
| Health condition(s) or problem(s) studied | Evaluation of active cervical spine range of motion in asymptomatic adults using a novel photogrammetric instrument as foundation for cervical spondylosis screening and diagnosis |
| Intervention | Current interventions as of 27/10/2025: A total of 530 asymptomatic adults participated in the measurement sessions assessing active cervical spine range of motion in six directions: flexion, extension, right and left side bending, and right and left rotation. Measurements were performed in standing position using both manual digital goniometry and the RomIX photogrammetric instrument. For RomIX, each participant stood at the center of the instrument and performed maximal active neck movements in each direction, holding for 5 seconds per movement. A single rater recorded all directions three times under identical conditions to determine test-retest reliability. The full RomIX procedure lasted approximately 5 minutes, with a 5-minute rest between repetitions. For manual goniometry, two independent clinicians performed all assessments following standardized protocols for flexion/extension, side bending, and rotation. Inter-rater reliability was evaluated by comparing results between the two clinicians, who were blinded to each other’s data. Each goniometric session took about 10 minutes, with a 5-minute break between repetitions. All conditions, including participant posture, device alignment, and measurement environment, were standardized to ensure reproducibility and to minimize measurement error. _____ Previous interventions as of 09/09/2024: 530 enrolled participants underwent the measurement sessions, where their neck range of motion in six directions (flexion, extension, right/left side bending, right/left rotation) was recorded using manual goniometry and the photogrammetric instrument. Each participant was examined using both methods, with the total duration of involvement being 15 minutes. The total duration of observation is 1 week, with a follow-up period of 2 weeks. Previous interventions: 50 enrolled participants underwent the measurement sessions, where their neck range of motion in six directions (flexion, extension, right/left side bending, right/left rotation) was recorded using manual goniometry and the photogrammetric instrument. Each participant was examined by both methods, respectively, with the total duration of involvement being 15 minutes. The total duration of observation is 1 week, with a follow-up period of 2 weeks. |
| Intervention type | Device |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | RomIX (photogrammetric instrument) |
| Primary outcome measure(s) |
Current primary outcome measure as of 27/10/2025: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 27/10/2025: |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 530 |
| Total final enrolment | 530 |
| Key inclusion criteria | Current key inclusion criteria as of 27/10/2025: Eligibility criteria for participants were adults aged 18 years or older, regardless of sex or occupation, who were actively participating in study, work, and normal daily activities. Inclusion criteria required that participants had a Visual Analog Scale (VAS) pain score of 0, a Neck Disability Index (NDI) score of ≤ 4, full cognitive and behavioral awareness, and voluntary agreement to participate. _____ Previous key inclusion criteria: 1. Participants are 18 years of age or older, regardless of gender or occupation. 2. Participants are capable of performing normal studying or working activities. 3. Participants have full cognitive and behavioral capacity. 4. Participants voluntarily agree to participate in the study. |
| Key exclusion criteria | Current key exclusion criteria as of 27/10/2025: Exclusion criteria included current or recent neck, shoulder, and/or headache symptoms within the previous 3 months; history of cervical spine or shoulder disorders; neurological and/or rheumatic conditions; and symptoms of nerve compression or radiculopathy. _____ Previous key exclusion criteria: 1. Participants report or complain of neck, shoulder and/or headache pain in the previous month. 2. Participants have history of neck and/or shoulder disorders, including trauma and fractures, history of neurological and/or rheumatic disorders. 3. Participants have history of other relevant medical conditions. |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 30/09/2024 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Ho Chi Minh City
751000
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the corresponding author (Dr Nguyen Huu Duc Minh, nhdminh@ump.edu.vn) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/10/2025 | Yes | No | ||
| Dataset | 28/10/2025 | No | No | ||
| Other files | Basic results (Phase 1 only) | 09/10/2024 | 09/10/2024 | No | No |
| Participant information sheet | 05/09/2024 | No | Yes | ||
| Participant information sheet | 09/09/2024 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 45926_PIS.pdf
- Participant information sheet
- ISRCTN10681217_PIS.pdf
- Participant information sheet
- ISRCTN10681217_BasicResults_Phase1_09Oct24.pdf
- Basic results (Phase 1 only)
- ISRCTN10681217 Basic result summary.pdf
- Results article
- ISRCTN10681217 Supplementary file_Data.docx
- Dataset
Editorial Notes
28/10/2025: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. A dataset was uploaded as an additional file.
27/10/2025: The following changes were made to the trial record:
1. The public title was changed from "New photogrammetric instrument for evaluating the cervical spine range of motion: clinical validity and gender study" to "New camera-based instrument to measure neck movement: its validity and sex differences in healthy adults".
2. The scientific title was changed from "Novel photogrammetric instrument to measure the cervical range of motion: validity and gender-based assessment in a clinical study" to "Novel photogrammetric instrument to measure cervical spine range of motion: test-retest reliability, construct validity, and sex-based assessment through a cross-sectional study on asymptomatic adults".
3. The study objectives were changed.
4. The study design was changed from "Single-centre cross-sectional study" to "Cross-sectional observational clinimetric study".
5. The condition was changed from "Evaluation of the cervical range of motion on healthy individuals using a photogrammetric instrument as fundamental for cervical spondylosis screening and diagnosis" to "Evaluation of active cervical spine range of motion in asymptomatic adults using a novel photogrammetric instrument as foundation for cervical spondylosis screening and diagnosis".
6. The interventions were changed.
7. The primary outcome measures were changed.
8. The secondary outcome measures were changed.
9. The study website was added.
10. The key inclusion criteria were changed.
11. The key exclusion criteria were changed.
12. The plain English summary was updated to reflect these changes.
09/10/2024: Basic results for phase 1 only.
08/10/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/09/2023 to 30/09/2024.
2. The overall study end date was changed from 31/12/2024 to 30/09/2024.
3. The intention to publish date was changed from 15/11/2024 to 30/12/2024.
09/09/2024: The following changes were made:
1. A later version of the patient information sheet was uploaded.
2. The Upper age limit (number) was changed from 40 to 60 and the plain English summary was updated to reflect this.
3. The interventions were changed.
4. The target number of participants and total final enrolment were changed from 50 to 530.
12/08/2024: Trial's existence confirmed by Ethics committee of University of Medicine and Pharmacy at Ho Chi Minh City.
