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临床试验/NCT07117292
NCT07117292尚未招募不适用

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

European University Cyprus1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
试验地点
1
主要终点
Agreement in Cervical Range of Motion between IMUs and Goniometer

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Agreement in Cervical Range of Motion between IMUs and Goniometer

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Pamboris

Assistant Professor of Biomechanics and Rehabilitation

European University Cyprus

研究点 (1)

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