An interventional study of Xsens DOT and Trigno Avanti Sensors in Cervical Spine Motion Assessment in Healthy Adults, sponsored by European University Cyprus. Not yet recruiting at 1 site in Cyprus. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by European University Cyprus · Not applicable, Interventional, and Diagnostic
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.
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.
European University Cyprus is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Xsens DOT · Device: Trigno Avanti Sensors · Device: Universal Goniometer
Wearable inertial sensor used to capture cervical range of motion in three planes.
Wearable inertial sensor used to capture cervical range of motion in three planes.
Standard clinical tool used to measure cervical spine motion angles manually.
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.
Time frame: 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).
Time frame: Day 1 (two repeated assessments within same session)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the main findings and will remain accessible for a minimum of 5 years.
Access criteria: Access to the IPD and supporting materials will be granted to qualified researchers affiliated with academic or research institutions for non-commercial use. Requests should be submitted to the principal investigator and will be evaluated based on the scientific merit of the proposal. Data will be shared via secure transfer through institutional repositories or encrypted platforms.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
European University Cyprus