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Идёт набор NCT07431151

Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients

Без фазы С лечением Stroke

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-Based Balance and Gait Training, Conventional Physiotherapy.
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 →
Официальное название

The Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Individuals With Subacute Stroke

Обзор

Stroke is one of the leading causes of long-term disability worldwide, and balance and gait impairments are common in the subacute phase, limiting activity performance and quality of life. Early and intensive rehabilitation during the first six months after stroke is considered critical for optimizing functional recovery. Virtual reality-based rehabilitation has emerged as a promising approach to enhance motor learning through task-specific, repetitive, and feedback-driven training. This randomized controlled trial aims to investigate the effects of intensive virtual reality-based balance and gait training on activity performance, balance confidence, and quality of life in individuals with subacute stroke. Participants will be randomly allocated to either an intervention group receiving conventional physiotherapy combined with additional virtual reality-based balance and gait training, or a control group receiving conventional physiotherapy alone during the study period. Outcome measures will include functional mobility, balance confidence, cognitive status, and stroke-specific quality of life. The findings of this study may contribute to optimizing rehabilitation intensity and timing strategies in subacute stroke rehabilitation

Подробное описание

Stroke is a leading cause of long-term disability worldwide. In the subacute phase, defined as the first six months after stroke, individuals frequently experience impaired balance, reduced gait adaptability, decreased activity performance, and diminished quality of life. Deficits in postural control and increased postural sway contribute to elevated fall risk and reduced community participation. Evidence suggests that the early post-stroke period represents a critical window for neuroplasticity, during which intensive and task-specific rehabilitation may significantly enhance motor recovery.

Virtual reality (VR)-based rehabilitation has emerged as an innovative therapeutic modality that integrates repetitive, task-oriented training with enriched multisensory feedback. VR systems provide real-time visual and auditory feedback, increase patient engagement, and promote motor learning principles such as high repetition, progressive challenge, and goal-directed practice. Previous studies have demonstrated that VR-based gait and balance training may improve functional mobility and postural control in stroke survivors. However, the optimal timing and intensity of such interventions during the subacute phase remain insufficiently explored.

This randomized controlled trial is designed to investigate the effects of intensive VR-based balance and gait training on activity performance, balance confidence, functional mobility, and stroke-specific quality of life in individuals with subacute stroke. Participants who meet the eligibility criteria will be randomly assigned to one of two parallel groups using a computer-generated randomization sequence.

All participants will receive routine conventional physiotherapy consisting of one hour of standard rehabilitation per session. In addition, the intervention group will receive an extra 30-minute session of VR-based balance and gait training per treatment day. The VR program includes progressive weight-shifting tasks, stepping exercises, and gait-related activities delivered through immersive or semi-immersive systems. Training intensity will be progressively adjusted according to individual performance levels, ensuring task-specific and graded motor challenge. Safety harness systems providing body-weight support will be used during sessions to minimize fall risk.

The control group will continue to receive conventional physiotherapy alone during the study period and will receive VR-based training after completion of the waiting period to ensure ethical balance. Outcome assessments will be conducted by a blinded assessor in a dedicated laboratory setting.

Primary and secondary outcomes will include functional mobility (Timed Up and Go Test), balance confidence (Activities-specific Balance Confidence Scale), cognitive status (Montreal Cognitive Assessment), functional ambulation level (Functional Ambulation Category), activity performance (Canadian Occupational Performance Measure), and stroke-specific quality of life (Stroke-Specific Quality of Life Scale). Assessments will be performed at baseline and immediately after completion of the intervention period.

The results of this study are expected to provide evidence regarding the effectiveness of intensified VR-based rehabilitation during the subacute phase of stroke and may contribute to optimizing rehabilitation timing and dosage strategies in clinical practice.

Вмешательства

  • Другое Virtual Reality-Based Balance and Gait Training
    Participants will receive an additional 30-minute session of virtual reality-based balance and gait training per treatment day for a total of 15 sessions, alongside routine conventional physiotherapy. The VR program will include task-specific exercises targeting balance and walking, such as weight-shifting, stepping, and gait-related tasks selected from a pre-defined exercise pool and individualized according to participant needs. Task difficulty will be progressed within and across sessions bas
  • Другое Conventional Physiotherapy
    Participants will receive routine conventional physiotherapy consisting of 60 minutes per session for a total of 15 sessions. The program will be delivered as part of standard inpatient/outpatient physiotherapy care and will include conventional rehabilitation components aimed at improving balance, mobility, and functional capacity, as clinically indicated.

Первичные конечные точки

  • Timed Up and Go Test [Срок оценки: Baseline and immediately after completion of the 15-session intervention period (15 days)]
  • Canadian Occupational Performance Measure [Срок оценки: Baseline and post-intervention (15 days)]
Вторичные конечные точки (3)
  • Activities-Specific Balance Confidence Scale [Срок оценки: Baseline and post-intervention (15 days)]
  • Stroke-Specific Quality of Life Scale [Срок оценки: Baseline and post-intervention (15 days)]
  • Functional Ambulation Category [Срок оценки: Baseline and post-intervention (15 days)]

Критерии участия

Критерии включения

  • Diagnosis of hemiplegia (ICD-10 code G81)
  • Age ≥ 18 years
  • Montreal Cognitive Assessment (MoCA) score > 10

Критерии исключения

  • Failure to attend three consecutive treatment sessions during the study period
  • Receiving additional balance- or gait-specific rehabilitation interventions (e.g., robot-assisted gait training) during the study period

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
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Bilkent City Hospital — Ankara

Идентификаторы

NCT: NCT07431151 · Stroke07

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗