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Not yet recruiting NCT07117292

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

No phase Interventional Cervical Spine Motion Assessment in Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xsens DOT, Trigno Avanti Sensors, Universal Goniometer.
Who it may be relevant to
Registry conditions: Cervical Spine Motion Assessment in Healthy Adults. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cyprus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Xsens DOT
    Wearable inertial sensor used to capture cervical range of motion in three planes.
  • Device Trigno Avanti Sensors
    Wearable inertial sensor used to capture cervical range of motion in three planes.
  • Device Universal Goniometer
    Standard clinical tool used to measure cervical spine motion angles manually.

Primary outcome measures

  • Agreement in Cervical Range of Motion between IMUs and Goniometer [Time frame: Day 1 (single-session assessment)]
  • Test-Retest Reliability of IMU Systems in Cervical Range of Motion [Time frame: Day 1 (two repeated assessments within same session)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Cyprus · 1 center
  • European University Cyprus — Nicosia

Identifiers

NCT: NCT07117292 · ΕΕΒΚ ΕΠ 2025.01.231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗