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

Not Applicable

Not yet recruiting

• Conditions: Cervical Spine Motion Assessment in Healthy Adults

• Registration Number: NCT07117292
• Lead Sponsor: European University Cyprus

Brief 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. 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 Timeline

• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement in Cervical Range of Motion between IMUs and Goniometer	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	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).

Trial Locations

Locations (1)

European University Cyprus; 🇨🇾 Nicosia, Cyprus