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

NCT ID: NCT07117292

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-31

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.

Conditions

Cervical Spine Motion Assessment in Healthy Adults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental: Sensor-Based Motion Assessment

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.

Group Type: EXPERIMENTAL

Xsens DOT

Intervention Type: DEVICE

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

Trigno Avanti Sensors

Intervention Type: DEVICE

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

Universal Goniometer

Intervention Type: DEVICE

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

Interventions

Xsens DOT

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

Intervention Type: DEVICE

Trigno Avanti Sensors

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

Intervention Type: DEVICE

Universal Goniometer

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brunel University

OTHER

Sponsor Role: collaborator

European University Cyprus

OTHER

Sponsor Role: lead

Responsible Party

George Pamboris

Assistant Professor of Biomechanics and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

European University Cyprus

Nicosia, , Cyprus

Countries

Cyprus

Central Contacts

George M. Pamboris, PhD

Role: CONTACT

G.Pamboris@euc.ac.cy

+35799336357

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ΕΕΒΚ ΕΠ 2025.01.231

Identifier Type: -

Identifier Source: org_study_id