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Набор скоро начнётся NCT07189052

Virtual Reality Program for Managing Chronic Neck Pain

Без фазы С лечением 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
В протоколе указаны: Virtual Reality Rehabilitation, Conventional Rehabilitation.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of a Virtual Reality-Based Rehabilitation Program on Pain and Function in Individuals With Chronic Neck Pain

Обзор

The goal of this clinical trial is to find out if a virtual reality-based rehabilitation program developed by our team can help people with chronic neck pain. The main questions it aims to answer are: * Does the VR program reduce neck pain? * Does it improve daily function and quality of life? Participants will: * Take part in a supervised virtual reality exercise program for 8 weeks, attending 3 sessions per week (24 sessions in total). * Each session will last about 45 minutes. * Complete tests and questionnaires about their pain, disability, and overall well-being before and after the program.

Подробное описание

This trial evaluates a virtual reality (VR)-based rehabilitation program developed by our team for people with chronic neck pain, compared against conventional therapy (CT) delivered as standard physiotherapy. Both programs share the same exercise components (breathing, stretching, range-of-motion, and posture-strengthening); the VR arm provides a game-adapted version in an immersive "beach and ocean" setting via a head-mounted display. Participants in both arms attend 20-minute sessions, twice per week over the intervention period.  

VR-Based Rehabilitation (Intervention)

The VR treatment module is structured into four components that run continuously within a beach-themed scenario:

* Breathing component: Before gameplay, participants are taught diaphragmatic breathing. In VR, the avatar starts on a deck chair by the sea; on-screen prompts guide the participant to inhale while lifting the head toward the sky and exhale while lowering toward the sand (approx. 5 minutes).  * Stretching component: The avatar rides a jet-ski along the shoreline and the participant collects coins arranged bilaterally, promoting controlled neck movements within the stretching block.  * Range-of-motion component: Therapeutic tasks cue cervical flexion, extension, lateral flexion (right/left), and rotation (right/left) as part of the game flow, mirroring the clinical ROM targets.  * Posture-strengthening component: Gamified tasks reinforce postural and scapular control consistent with the conventional program's strengthening principles. 

Overall, the VR arm delivers the same exercise content as CT, but as a game-adapted version in an immersive beach setting via VR glasses. 

Conventional Therapy (Comparator)

The CT arm performs the same exercise categories as standard, therapist-guided physiotherapy with predefined sets/repetitions:

* Diaphragmatic breathing: 10 repetitions.  * Stretching: Trapezius (right and left) - 10 repetitions × 15 seconds each side.  * Neck ROM exercises: Flexion \& extension; right/left lateral flexion; right/left rotation - 10 repetitions × 5 seconds per movement.  * Posture-strengthening: Proprioceptive Neuromuscular Facilitation (PNF)-based scapular retraction - 3 sets × 10 repetitions (with facilitation at the start of each series). 

Dose \& schedule: Both arms follow 20-minute sessions, twice weekly; outcomes (e.g., pain, disability, kinesiophobia, quality of life) are recorded pre-/post-intervention (detailed in the Outcomes section).

Вмешательства

  • Другое Virtual Reality Rehabilitation
    A virtual reality-based rehabilitation program including breathing, stretching, cervical range-of-motion, and posture-strengthening tasks delivered in a gamified seaside environment using a head-mounted VR display. Sessions will last 20 minutes, performed twice per week for 8 weeks (16 sessions total) under supervision.
  • Другое Conventional Rehabilitation
    Standard physiotherapy including diaphragmatic breathing, trapezius stretching, cervical range-of-motion, and posture-strengthening with proprioceptive neuromuscular facilitation. Sessions will last 20 minutes, performed twice per week for 8 weeks (16 sessions total) under supervision.

Первичные конечные точки

  • Pain Intensity [Срок оценки: Baseline and at the end of the study.]
  • Neck Disability [Срок оценки: Baseline and at the end of the study.]
  • Cervical Range of Motion [Срок оценки: Baseline and at the end of the study.]
  • Proprioception [Срок оценки: Baseline and at the end of the study.]
Вторичные конечные точки (4)
  • Life Quality [Срок оценки: Baseline and at the end of the study.]
  • Kinesiophobia [Срок оценки: Baseline and at the end of the study.]
  • Treatment Adherence [Срок оценки: At the end of the study.]
  • Participant Satisfication [Срок оценки: At the end of the study.]

Критерии участия

Критерии включения

  • Age 18-65 years
  • Diagnosis of chronic neck pain (≥ 6 months duration)
  • Ability to participate in rehabilitation sessions
  • Willingness to provide written informed consent

Критерии исключения

  • Previous adverse experience with virtual reality
  • Photophobia (UPSIS-12 score > 12)
  • Migraine (≥ 2 positive responses on ID-Migraine questionnaire)
  • Presence of any neurological deficit
  • History of spinal surgery
  • Medical conditions interfering with participation, including orthopedic, inflammatory, cardiovascular, rheumatologic, or vestibular disorders
  • Pregnancy
  • Epilepsy or other neurological conditions causing photosensitivity
  • Congenital spinal cord malformations

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

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

Публикации

  • Ruf M, Welk T, Muller M, Merk HR, Harms J. Ventral cancellous bone augmentation of the dens and temporary instrumentation C1/C2 as a function-preserving option in the treatment of dens pseudarthrosis. J Spinal Disord Tech. 2010 Jun;23(4):285-92. doi: 10.1097/BSD.0b013e3181aac6ff. PMID 20110831

Идентификаторы

NCT: NCT07189052 · VRTR34T

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗