New photogrammetric instrument for evaluating the cervical spine range of motion: clinical validity and gender study
| ISRCTN | ISRCTN10681217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10681217 |
| Secondary identifying numbers | No. 2021-00020-3 |
- Submission date
- 12/08/2024
- Registration date
- 05/09/2024
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Neck pain and other issues related to the cervical spine are common problems that can significantly affect people's lives. Diagnosing and treating these conditions often require precise measurements of neck movement. This study focuses on the development and validation of a new instrument called RomIX, which is designed to measure the motion of the cervical spine accurately, which includes a comparison of its performance regarding reliability and validity with existing goniometry.
Who can participate?
Healthy adults 18 - 60 years old
What does the study involve?
Participants are involved to calibrate the instrument and establish a normative standard range-of-motion value for healthy individuals. Participants in the study had their neck movements measured using the RomIX in six directions (flexion, extension, right/left side bending, and right/left rotation). The data were compared with manual goniometric results to examine its accuracy.
What are the possible benefits and risks of participating?
Participants in this study can contribute to the development of a new medical device that could improve the diagnosis and treatment of neck problems. RomIX could be particularly useful for healthcare professionals in diagnosing and treating neck-related issues, offering a non-invasive, accurate, and user-friendly method for assessing cervical spine motion.
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) (South Korea)
Who is the main contact?
Mr. Minh Nguyen Huu Duc (MD in Traditional Medicine, 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
| Study design | Single-centre cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 45926_PIS.pdf |
| Scientific title | Novel photogrammetric instrument to measure the cervical range of motion: validity and gender-based assessment in a clinical study |
| 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 the cervical range of motion on healthy individuals using a photogrammetric instrument as fundamental for cervical spondylosis screening and diagnosis |
| Intervention | Current interventions: 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | RomIX (photogrammetric instrument) |
| Primary outcome measure | Cervical spine range of motion measured in six directions (flexion, extension, right/left side bending, right/left rotation) by goniometry and the the photogrammetric instrument at baseline |
| Secondary outcome measures | Intraclass correlation (ICC), standard error of measurement (SEM), minimal detectable change (MDC), and Pearson’s correlation coefficient (r) calculated from neck range-of-motion at baseline |
| Overall study start date | 01/05/2023 |
| 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 | Both |
| Target number of participants | 530 |
| Total final enrolment | 530 |
| 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 | 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
Sponsor information
University/education
217 Hong Bang Street, Ward 11, District 5
Ho Chi Minh City
748000
Viet Nam
| Phone | +84 2838558411 |
|---|---|
| hanhchinh@ump.edu.vn | |
| Website | https://ump.edu.vn/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- KOICA
- Location
- Korea, South
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the corresponding author (Mr Minh Nguyen Huu Duc, nhdminh@ump.edu.vn) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 05/09/2024 | No | Yes | ||
| Participant information sheet | 09/09/2024 | No | Yes | ||
| Other files | Basic results (Phase 1 only) | 09/10/2024 | 09/10/2024 | No | No |
Additional files
- 45926_PIS.pdf
- ISRCTN10681217_PIS.pdf
- ISRCTN10681217_BasicResults_Phase1_09Oct24.pdf
- Basic results (Phase 1 only)
Editorial Notes
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.
