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Набор скоро начнётся NCT07190014

Virtual Reality Application for Assessing Neck Movement and Position Sense

— Наблюдательное Chronic Neck Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Neck Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigation of the Effects of a Virtual Reality Application Developed for the Assessment of Cervical Joint Range of Motion and Joint Position Sense

Обзор

The goal of this observational study is to examine whether a virtual reality application developed by our team can be used to evaluate cervical range of motion (ROM) and joint position sense (JPS) in individuals with chronic neck pain. The main questions it aims to answer are: * Does the virtual reality application provide reliable measurements of cervical ROM? * Does the application accurately assess cervical JPS when compared with a standard clinical tool (Cervical Range of Motion device, CROM)? Researchers will compare results from the VR application with results from the CROM device to see if the two methods give similar outcomes. Participants will: * Complete a demographic and clinical evaluation. * Perform standardized neck movements (flexion, extension, left/right lateral flexion, left/right rotation). * Be assessed using both the CROM device and the VR application for ROM and JPS.

Подробное описание

Neck pain is one of the most common musculoskeletal problems and is associated with limitations in mobility and proprioceptive deficits. Reliable assessment of cervical range of motion (ROM) and joint position sense (JPS) is critical for both clinical evaluation and rehabilitation planning. Traditional devices, such as the Cervical Range of Motion (CROM) instrument, are widely used but have limitations, including the need for manual operation, restricted visualization, and lower potential for patient engagement.

Virtual reality (VR) technologies provide an opportunity to overcome these limitations by offering objective measurements, immersive feedback, and greater standardization of the testing environment. Our team has developed a VR-based application specifically designed to assess cervical ROM and JPS. This application may contribute to more accurate, reliable, and user-friendly evaluation methods compared to conventional tools.

In this observational study, individuals with chronic neck pain will be assessed using both the CROM device and the VR application. The study will compare the results obtained from both methods to determine the validity and reliability of the VR-based system.

The findings are expected to provide evidence for the clinical use of VR in musculoskeletal assessment, potentially enhancing diagnostic accuracy and supporting the development of innovative rehabilitation strategies.

Первичные конечные точки

  • Cervical Range of Motion (ROM) Measurements [Срок оценки: At baseline, during a single assessment session (Day 1).]
  • Cervical Joint Position Sense (JPS) Error [Срок оценки: At baseline, during a single assessment session (Day 1).]
Вторичные конечные точки (3)
  • Usability and Participant Experience [Срок оценки: Immediately after completion of the VR assessment session (Day 1).]
  • Simulator Sickness Questionnaire (SSQ) Scores [Срок оценки: Immediately after completion of the VR assessment session (Day 1).]
  • Assessment Duration [Срок оценки: During the single assessment session (Day 1).]

Критерии участия

Критерии включения

  • Chronic Neck Pain (CNP) participants
  • Age 18-65. 
  • ≥ 6 months of neck pain. 
  • Willing to participate (informed consent). 

Healthy volunteers

  • Age 18-65. 
  • No neck pain complaints. 
  • Willing to participate (informed consent). 

Критерии исключения

  • Prior adverse virtual reality experience. 
  • Photophobia: UPSIS-12 score > 12. 
  • Migraine screen: ≥2 "yes" on ID-Migraine. 
  • Any neurological deficit. 
  • History of spinal surgery. 
  • Medical conditions that could interfere with participation: orthopedic, inflammatory, cardiovascular, rheumatologic, or vestibular problems. 
  • Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe University Hospital Department of Neurosurgery — Ankara

Публикации

  • Sarig Bahat H, Takasaki H, Chen X, Bet-Or Y, Treleaven J. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial. Man Ther. 2015 Feb;20(1):68-78. doi: 10.1016/j.math.2014.06.008. Epub 2014 Jul 5. PMID 25066503

Идентификаторы

NCT: NCT07190014 · VRROMJPSEV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗