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Идёт набор NCT06152328

Virtual Reality Based Mirror Therapy

Без фазы С лечением Stroke Upper Extremity Paresis Upper Extremity Paralysis

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 applications based on mirror therapy, Conventional treatment, Mirror therapy, Placebo virtual reality.
Кому может быть актуально
Состояния в реестре: Stroke, Upper Extremity Paresis, Upper Extremity Paralysis. Базовые параметры: 40 лет — 80 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

A New Perspective on Mirror Therapy: The Effect of Leap Motion-Based Multi-Axis Immersive Virtual Reality Mirror Therapy (LISA) on Upper Extremity Functions in Individuals With Stroke

Обзор

The aim of this study is to examine the effectiveness of 3D virtual reality assisted mirror therapy based rehabilitation applications compared to classical methods used in stroke rehabilitation.

Подробное описание

Stroke is a common neurological condition and one of the significant causes of disability and death. For this reason, stroke is one of the leading causes of disability in adulthood and increases health expenditures in this area. Post-stroke rehabilitation is effective in accelerating recovery and reducing the impact of long-term disabilities, but more studies are needed to understand its specific implications.

Virtual reality applications are a method that has been developing rapidly with the development of technology since the 1980s and is used more widely in simulations and games today. Virtual reality and interactive video games have started to be used as a new treatment method in stroke rehabilitation. The advantage of this method is that it allows the patient to use activity methods that cannot be reached or used in the clinical setting, with plenty of repetitive and visual feedback. Moreover, virtual reality programs are designed to be more entertaining and sustainable for a long time compared to traditional treatment programs. There are no virtual reality devices specially designed for treatment, but the game consoles used in the market are modified for this purpose and used comfortably.

Oculus rift is a console that can create a real virtual reality environment. The individual has a realistic experience by seeing his own avatar and interacting with objects in a world where he will be 360-degree interactive in a designed environment completely isolated from the external environment. It is the most advanced technology of virtual reality applications used today, and it increases the individual's feeling of being in a 3D environment with glasses that use the entire visual field of the person and headphones for the transmission of sounds.

As an alternative treatment approach, mirror therapy has been suggested to be beneficial. Unlike other interventions that use somatosensory input to aid motor recovery, mirror therapy relies on visual stimulation. During mirror therapy, a mirror is placed in the patient's midsagittal plane so that the nonparetic side is mirrored as if it were the affected side. The advantages of mirror therapy are that it is relatively easy to administer and can be self-administered, even for patients with severe motor deficits.

Mirror therapy is claimed to alleviate post-stroke hemiparesis. Studies confirm the positive effects of mirror therapy on patients' mobility in post-stroke upper extremity hemiparesis. The concept of mirror therapy is explained neurophysiologically. Evidence suggests that the same cortical motor areas that are active during the observation of movements are involved in the performance of observed actions.

With the environment to be prepared in virtual reality, the individual will see the exact copy of the movements of the healthy side as the movement of the affected extremity. According to the activity to be selected, the image will be projected as if the affected side is doing the same or the opposite movement. Oculus rift has a structure that covers the entire field of vision with its glasses-shaped apparatus and insulates sounds from outside with its earphones. In this way, it will give the person the feeling of being in the environment much more than the non-immersive virtual reality treatments frequently used in previous studies. The person will see the avatar created in the virtual world in real-time, and the movements will turn into an instant image. The image will cover the person's visual field as in the real world, and the person will see their own body through their own eyes throughout the application.

Вмешательства

  • Другое Virtual reality applications based on mirror therapy
    Mirror therapy-based games will be played for 30 minutes every day for eight weeks, three days a week, for the VR group.
  • Другое Conventional treatment
    Bobath therapy, walking exercises, upper extremity active exercises, and proprioceptive neuromuscular facilitation techniques will be applied three days a week for eight weeks.
  • Другое Mirror therapy
    In conventional mirror therapy, the unaffected extremities of the individuals will be positioned outside the mirror, while the affected extremities will be placed inside the mirror so that the patient cannot see them. In this way, the image of the intact hand will be transferred to the affected side and activities will be performed three days a week for eight weeks.
  • Другое Placebo virtual reality
    For 8 weeks, watching the uninteractive virtual environment

Первичные конечные точки

  • Fugl-Meyer Assessment [Срок оценки: 8 Weeks]
Вторичные конечные точки (5)
  • Evaluation of Cortical Activation with EEG [Срок оценки: 8 Weeks]
  • Motor Activity Log-28 [Срок оценки: 8 Weeks]
  • Simulator Sickness Questionnaire [Срок оценки: 8 Weeks]
  • System Usability Scale [Срок оценки: 8 Weeks]
  • Stroke-Specific Quality of Life Scale [Срок оценки: 8 Weeks]

Критерии участия

Критерии включения

  • Have a ischemic stroke
  • Stroke duration not less than 2 months and not more than 6 months
  • Individuals with a score of 2b and 3 according to the Thrombolysis in cerebral infarction (TICI) scale
  • A score of 2 and above according to the upper extremity motor assessment of the NIH stroke scale
  • Intact depth perception in the Titmus Stereopsis assessment
  • A score of 24 and above in the Mini-mental test and
  • Independent sitting balance

Критерии исключения

  • Additional neurologic diseases
  • Have a head injury
  • Have a brain tumor
  • Prior cranial surgery
  • Psychological disorder or mental problem
  • Previous stroke
  • Aphasia and apraxia
  • Upper extremity amputation

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
  • Abant Izzet Baysal University Faculty of Health Science — Bolu

Идентификаторы

NCT: NCT06152328 · AIBU-FTR-BENLI-004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗