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NCT Number: NCT07117292

Assessing the Validity and Reliability of IMU Systems and a Goniometer in Cervical Motion (VIRGO-CM)

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.

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Key information

Conditions

Cervical Spine Motion Assessment in Healthy Adults

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European University Cyprus

Nicosia, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged 18 to 40 years
  • Able to understand and follow instructions
  • Provided informed consent

Exclusion criteria

  • 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

Treatment and study plan

Xsens DOT

Device

Wearable inertial sensor used to capture cervical range of motion in three planes.

Trigno Avanti Sensors

Device

Wearable inertial sensor used to capture cervical range of motion in three planes.

Universal Goniometer

Device

Standard clinical tool used to measure cervical spine motion angles manually.

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

George M. Pamboris, PhD

CONTACT

[email protected]

+35799336357

Sponsors and collaborators

Lead sponsor

European University Cyprus

Other

Collaborators

  • Brunel University

Registry information

Official study title

Assessing the Validity and Reliability of Two IMU Sensor Systems and a Goniometer in Multi-Planar Cervical Motion

Acronym: VIRGO-CM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.