Cervical Spine Motion Assessment in Healthy AdultsVIRGO-CMNCT07117292
Assessing the Validity and Reliability of IMU Systems and a Goniometer in Cervical Motion (VIRGO-CM)
A study testing Xsens DOT, Trigno Avanti Sensors and Universal Goniometer in people with Cervical Spine Motion Assessment in Healthy Adults, run by European University Cyprus at 1 site in Cyprus.
Trial summary
This study aims to evaluate how accurate and reliable two wearable sensor systems (inertial measurement units or IMUs) and a goniometer are in measuring cervical spine (neck) motion. Healthy adult volunteers will be asked to perform simple head movements in different directions while being assessed using the devices. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Motion Assessment in Healthy Adults
- What is being tested?
- Xsens DOT, Trigno Avanti Sensors and Universal Goniometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCyprus
- Study dates
- Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 40 years
- Able to understand and follow instructions
- Provided informed consent
Who cannot join
- History of cervical spine pathology, trauma, or surgery
- Presence of neck pain, musculoskeletal, neurological, or vestibular disorders
- Use of medications affecting sensorimotor function
- Pregnancy
- Any condition that may interfere with safe participation or data accuracy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Validity and Reliability of Two IMU Sensor Systems and a Goniometer in Multi-Planar Cervical Motion
This study aims to evaluate how accurate and reliable two wearable sensor systems (inertial measurement units or IMUs) and a goniometer are in measuring cervical spine (neck) motion. Healthy adult volunteers will be asked to perform simple head movements in different directions while being assessed using the devices. The goal is to compare how closely these tools agree with each other and how consistently they record motion across repeated tests. This information will help determine whether the sensors are suitable for use in clinical settings to assess neck movement in future patient populations.
Read the detailed description
This interventional validation study will assess the concurrent validity and test-retest reliability of two inertial measurement unit (IMU) systems (Xsens DOT and Trigno Avanti) and a universal goniometer in measuring multi-planar cervical motion. A within-subject design will be used, with participants performing standardized active cervical range of motion (AROM) tasks in flexion, extension, lateral flexion, and rotation. All measurements will be conducted in a biomechanics lab setting under controlled conditions.
Each participant will undergo three testing sessions:
Familiarization session (optional)
Test session 1
Test session 2
Primary outcomes will include:
Peak angular displacement in each movement plane
Inter-device agreement (validity)
Intra-device test-retest consistency (reliability)
Sensor placement will follow anatomical landmarks based on previous biomechanical research. The IMUs and goniometer will be used simultaneously to compare measurements. Data analysis will involve intraclass correlation coefficients (ICC), standard error of measurement (SEM), and Bland-Altman plots for agreement analysis.
The study will recruit 20-30 healthy adults aged 18-40 with no current or past neck injury. The results will inform future clinical applications of wearable sensors in cervical spine assessment, particularly for populations with neck pain or neuromusculoskeletal disorders.
Ethical approval has been granted by the Cyprus National Bioethics Committee (Approval: ΕΕΒΚ ΕΠ 2025.01.231), and all participants will provide written informed consent.
- Being tested
- Xsens DOT, Trigno Avanti Sensors, Universal Goniometer
- Keywords
- Inertial Measurement Units (IMUs), Cervical Spine, Wearable Sensors, Validity, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xsens DOTDevice
Wearable inertial sensor used to capture cervical range of motion in three planes.
Trigno Avanti SensorsDevice
Wearable inertial sensor used to capture cervical range of motion in three planes.
Universal GoniometerDevice
Standard clinical tool used to measure cervical spine motion angles manually.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Sensor-Based Motion Assessment | Experimental | Participants will undergo two testing assessments of cervical spine motion using three devices: Xsens DOT (IMU), Trigno Avanti (IMU), and a universal goniometer. The aim is to assess the validity and reliability of the sensor systems. Receives: Device: Xsens DOT; Device: Trigno Avanti Sensors; Device: Universal Goniometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in Cervical Range of Motion between IMUs and Goniometer
Assessment of the validity of two inertial measurement units (Xsens DOT and Trigno Avanti) compared to a universal goniometer in measuring active cervical spine range of motion across flexion/extension, lateral flexion, and axial rotation using Bland-Altman analysis.
Measured: Day 1 (single-session assessment)
Test-Retest Reliability of IMU Systems in Cervical Range of Motion
Evaluation of intra-session and inter-session test-retest reliability of Xsens DOT and Trigno Avanti inertial sensors in measuring active cervical range of motion (CROM) across three planes (flexion/extension, lateral flexion, rotation). Reliability will be quantified using intraclass correlation coefficients (ICC) and standard error of measurement (SEM).
Measured: Day 1 (two repeated assessments within same session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine Motion Assessment in Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo the same testing protocol across two sessions. No comparison groups or treatment arms are used. The study involves repeated measures within the same group to assess inter-device validity and intra-device reliability of cervical spine motion measurements.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University
- Responsible party
- Principal investigator, George Pamboris, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117292
- Sponsor's protocol ID
- ΕΕΒΚ ΕΠ 2025.01.231
- Acronym
- VIRGO-CM
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including cervical range of motion measurements and sensor-derived outputs, will be made available upon reasonable request for secondary analysis. Data will be shared via a secure university repository or data-sharing platform following study completion and publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Validity and Reliability of Two IMU Sensor Systems and a Goniometer in Multi-Planar Cervical Motion
- ClinicalTrials.gov ID
- NCT07117292
- Acronym / sponsor ID
- VIRGO-CM / ΕΕΒΚ ΕΠ 2025.01.231
- Keywords
- Inertial Measurement Units (IMUs), Cervical Spine, Wearable Sensors, Validity, Reliability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Collaborators
- Brunel University
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate how accurate and reliable two wearable sensor systems (inertial measurement units or IMUs) and a goniometer are in measuring cervical spine (neck) motion. Healthy adult volunteers will be asked to perform simple head movements in different directions while being assessed using the devices. The goal is to compare how closely these tools agree with each other and how consistently they record motion across repeated tests. This information will help determine whether the sensors are suitable for use in clinical settings to assess neck movement in future patient populations.
Detailed description
This interventional validation study will assess the concurrent validity and test-retest reliability of two inertial measurement unit (IMU) systems (Xsens DOT and Trigno Avanti) and a universal goniometer in measuring multi-planar cervical motion. A within-subject design will be used, with participants performing standardized active cervical range of motion (AROM) tasks in flexion, extension, lateral flexion, and rotation. All measurements will be conducted in a biomechanics lab setting under controlled conditions.
Each participant will undergo three testing sessions:
Familiarization session (optional)
Test session 1
Test session 2
Primary outcomes will include:
Peak angular displacement in each movement plane
Inter-device agreement (validity)
Intra-device test-retest consistency (reliability)
Sensor placement will follow anatomical landmarks based on previous biomechanical research. The IMUs and goniometer will be used simultaneously to compare measurements. Data analysis will involve intraclass correlation coefficients (ICC), standard error of measurement (SEM), and Bland-Altman plots for agreement analysis.
The study will recruit 20-30 healthy adults aged 18-40 with no current or past neck injury. The results will inform future clinical applications of wearable sensors in cervical spine assessment, particularly for populations with neck pain or neuromusculoskeletal disorders.
Ethical approval has been granted by the Cyprus National Bioethics Committee (Approval: ΕΕΒΚ ΕΠ 2025.01.231), and all participants will provide written informed consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo the same testing protocol across two sessions. No comparison groups or treatment arms are used. The study involves repeated measures within the same group to assess inter-device validity and intra-device reliability of cervical spine motion measurements.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sensor-Based Motion Assessment | Experimental | Device: Xsens DOT, Device: Trigno Avanti Sensors, Device: Universal GoniometerParticipants will undergo two testing assessments of cervical spine motion using three devices: Xsens DOT (IMU), Trigno Avanti (IMU), and a universal goniometer. The aim is to assess the validity and reliability of the sensor systems. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18 to 40 years
- Able to understand and follow instructions
- Provided informed consent
Key exclusion criteria (5 listed)
- History of cervical spine pathology, trauma, or surgery
- Presence of neck pain, musculoskeletal, neurological, or vestibular disorders
- Use of medications affecting sensorimotor function
- Pregnancy
- Any condition that may interfere with safe participation or data accuracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xsens DOTWearable inertial sensor used to capture cervical range of motion in three planes. | Device | Experimental: Sensor-Based Motion Assessment |
| Trigno Avanti SensorsWearable inertial sensor used to capture cervical range of motion in three planes. | Device | Experimental: Sensor-Based Motion Assessment |
| Universal GoniometerStandard clinical tool used to measure cervical spine motion angles manually. | Device | Experimental: Sensor-Based Motion Assessment |
Primary outcome
Agreement in Cervical Range of Motion between IMUs and Goniometer
Time frame: Day 1 (single-session assessment)
Assessment of the validity of two inertial measurement units (Xsens DOT and Trigno Avanti) compared to a universal goniometer in measuring active cervical spine range of motion across flexion/extension, lateral flexion, and axial rotation using Bland-Altman analysis.
Test-Retest Reliability of IMU Systems in Cervical Range of Motion
Time frame: Day 1 (two repeated assessments within same session)
Evaluation of intra-session and inter-session test-retest reliability of Xsens DOT and Trigno Avanti inertial sensors in measuring active cervical range of motion (CROM) across three planes (flexion/extension, lateral flexion, rotation). Reliability will be quantified using intraclass correlation coefficients (ICC) and standard error of measurement (SEM).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including cervical range of motion measurements and sensor-derived outputs, will be made available upon reasonable request for secondary analysis. Data will be shared via a secure university repository or data-sharing platform following study completion and publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xsens DOT, Trigno Avanti Sensors and Universal Goniometer in people with Cervical Spine Motion Assessment in Healthy Adults, run by European University Cyprus at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George M. Pamboris, PhD (+35799336357, G.Pamboris@euc.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Cervical Range of Motion between IMUs and Goniometer (time frame: Day 1 (single-session assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.