The Effects of Augmented Reality Versus Virtual Reality
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: Augmented Reality, Virtual Reality, Self Directed Exercises, Others.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: от 18 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 →
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Официальное название
Effects of Augmented Reality and Virtual Reality-Assisted Gait Training on Balance and Walking in Individuals With Stroke
Обзор
This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). A total of 66 post-stroke patients will be randomly assigned to three groups: (1) VR group receiving gait training via C-Mill VR applications in addition to conventional physiotherapy, (2) AR group receiving gait training via C-Mill AR applications in addition to conventional physiotherapy, and (3) control group receiving a home exercise program alongside conventional physiotherapy. Participants will train for 45 minutes per day, five days a week, for three weeks. Outcome measures will include clinical, functional, cognitive, and spatiotemporal gait parameters to evaluate changes in balance and walking ability before and after the intervention.
Подробное описание
This prospective, randomized controlled study aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, and to contribute to the literature through a comprehensive analysis within the International Classification of Functioning, Disability and Health (ICF) framework. Stroke is a leading cause of long-term disability and care burden, with nearly one-third of acute stroke survivors unable to walk three months after onset. Improving walking ability is a central goal of stroke rehabilitation. There is increasing evidence that high-intensity, task-specific, and repetitive training can enhance functional recovery. Treadmill training enables intensive, repetitive practice of complex gait patterns and has been shown to improve walking speed and distance in stroke survivors. Technological advances have introduced immersive tools such as VR and AR systems into rehabilitation, providing engaging and interactive environments that enhance motor learning and patient motivation.
The C-Mill VR+ system (Motek, Netherlands) is a treadmill equipped with both AR and VR applications, offering visual-auditory feedback, safety harnesses, and force sensors. Though studies suggest C-Mill training improves gait and reduces fall risk in geriatric and Parkinson's disease populations, comprehensive randomized controlled trials comparing AR- and VR-supported treadmill training in stroke rehabilitation are lacking.
This study will enroll 66 individuals with stroke undergoing inpatient rehabilitation at the Virtual Reality Laboratory of Ankara Bilkent City Hospital. Inclusion criteria include diagnosis of hemiplegia (ICD-10 code G81), age 18 or older, and ability to walk with or without assistance (Functional Ambulation Classification ≥ 2). Exclusion criteria include aphasia, MoCA score \<10, additional neurological/orthopedic problems, recurrent stroke, or a Modified Ashworth Scale (MAS) score of 3-4 in the lower extremities. Participants will be randomly assigned to one of three groups: (1) VR group-C-Mill VR treadmill training with Nature Island, Italian Apps, and Soccer applications; (2) AR group-C-Mill AR training using Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game applications; (3) Control group-home-based walking exercises (flat ground, variable step length, obstacles, and speed) in addition to standard physiotherapy. All groups will continue routine physiotherapy and receive 45-minute training sessions, five days a week for three weeks.
Outcome measures assessed pre- and post-intervention include the Timed Up and Go Test, Fugl-Meyer Lower Extremity Motor Assessment, Modified Ashworth Scale, Activities-specific Balance Confidence Scale, Berg Balance Scale, Functional Ambulation Classification, Trunk Impairment Scale, Stroke Impact Scale (3.0), Stroke-Specific Quality of Life Scale, Montreal Cognitive Assessment (MoCA), and spatiotemporal gait analysis via the C-Mill VR+ system. Gait analysis will record step lengths, stance and swing phases, and double support percentages for both paretic and non-paretic limbs at self-selected and fixed speeds.
Вмешательства
- Другое Augmented Reality
Gait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes. - Другое Virtual Reality
Gait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes. - Другое Self Directed Exercises
"Patients will be taught exercises including walking on a flat surface, walking with varying step lengths, walking over obstacles, and walking at different speeds. They will be instructed to perform these exercises for 45 minutes per day. - Другое Others
The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars,
Первичные конечные точки
- Timed Up and Go (TUG) Test [Срок оценки: baseline and after 3 weeks]
- Berg Balance Scale (BBS) [Срок оценки: baseline and after 3 weeks]
- Gait Analsis [Срок оценки: baseline and after 3 weeks]
Вторичные конечные точки (6)
- Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE) [Срок оценки: baseline and after 3 weeks]
- Activities-specific Balance Confidence (ABC) Scale [Срок оценки: baseline and after 3 weeks]
- Functional Ambulation Category (FAC) [Срок оценки: baseline and after 3 weeks]
- Trunk Impairment Scale (TIS) [Срок оценки: baseline and after 3 weeks]
- Stroke Impact Scale (SIS) Version 3.0 [Срок оценки: baseline and after 3 weeks]
- Stroke-Specific Quality of Life Scale (SS-QOL) [Срок оценки: baseline and after 3 weeks]
Критерии участия
Критерии включения
- ICD-10 diagnosis code of G.81 (Hemiplegia)
- Age 18 years or older
- Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)
Критерии исключения
- Incomplete completion of the assessment form
- Refusal to participate in the study
- Aphasia
- Montreal Cognitive Assessment score below 10
- Presence of extra neurological or orthopedic problems unrelated to stroke
- Recurrent stroke
- MAS score of 3-4 (lower extremity)
- Volunteer's desire to withdraw from the study
- Inability to adapt to the technological devices used in the study (e.g., visual or hearing impairments)
- Missing three consecutive treatment sessions
- Botulinum toxin-A (BONT-A) injection to the lower extremity during the treatment process or within the last 6 months
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
- Простое слепое
- Основная цель
- Другое
Центры проведения
Turkey (Türkiye) · 1 центр
- Ankara Bilkent City Hospital — Ankara
Идентификаторы
NCT: NCT07113093 · VR02