Body Weight-Supported and Virtual Reality Gait Training in Stroke Patients

Официальное название

A Comparative Evaluation of the Effectiveness of Body Weight-Supported Forward and Backward Gait Training Versus Virtual Reality-Assisted Gait Training in Patients With Stroke

Обзор

The aim of this study is to compare the effects of body weight-supported gait training that includes virtual reality-assisted dual-task applications with body weight-supported forward and backward gait training on functional capacity, gait parameters (such as step length, gait speed, and balance), cognitive functions and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility in patients with stroke

Подробное описание

Stroke is a leading cause of disability worldwide and often results in motor, balance, and cognitive impairments that negatively affect functional independence and quality of life. Walking limitations are among the most common consequences after stroke and represent a major barrier to community participation. Therefore, improving gait performance and functional mobility is a primary goal of stroke rehabilitation.

Body weight-supported gait training is widely used to improve walking ability in individuals with impaired balance and reduced motor function. In recent years, rehabilitation technologies such as virtual reality-assisted gait training have been increasingly incorporated into clinical practice. Virtual reality may enhance patient engagement and promote both motor and cognitive recovery by providing interactive environments and increasing task demands.

Backward walking training has also gained attention as an alternative rehabilitation approach. Compared to forward walking, backward walking requires greater postural control and cognitive processing, similar to dual-task training, and may contribute to improvements in balance and gait performance. However, there is limited evidence directly comparing virtual reality-assisted dual-task gait training with backward walking training in patients with stroke.

This study aims to compare the effects of body weight-supported virtual reality-assisted dual-task gait training and body weight-supported forward and backward gait training on functional capacity, gait parameters, cognitive functions, and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility and functional outcomes in stroke rehabilitation.

Вмешательства

• Другое Virtual Reality-Assisted Gait Training
  Body weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks.
• Другое Backward Gait Training
  Body weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks.
• Другое Forward Gait Training
  Body weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks.

Первичные конечные точки

• 10-Meter Walk Test [Срок оценки: At baseline and after 6 weeks of intervention.]

Вторичные конечные точки (12)

• 6-Minute Walk Test (6MWT) [Срок оценки: At baseline and after 6 weeks of intervention]
• Fugl-Meyer Assessment - Lower Extremity Motor Subscale [Срок оценки: At baseline and after 6 weeks of intervention]
• Functional Independence Measure (FIM) [Срок оценки: At baseline and after 6 weeks of intervention.]
• Berg Balance Scale (BBS) [Срок оценки: At baseline and after 6 weeks of intervention.]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: At baseline and after 6 weeks of intervention.]
• Stroke-Specific Quality of Life Scale (SS-QOL) [Срок оценки: At baseline and after 6 weeks of intervention.]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: At baseline and after 6 weeks of intervention.]
• Foot Rotation [Срок оценки: At baseline and after 6 weeks of intervention.]
• Step Width [Срок оценки: At baseline and after 6 weeks of intervention.]
• Step Length [Срок оценки: At baseline and after 6 weeks of intervention.]
• Stance Phase [Срок оценки: At baseline and after 6 weeks of intervention.]
• Swing Phase [Срок оценки: At baseline and after 6 weeks of intervention.]

Критерии участия

Критерии включения

• Patients experiencing their first-ever stroke
• Patients with a post-stroke duration of more than 2 weeks
• Patients with plantar flexor muscle spasticity of the lower extremity less than grade 3 according to the Modified Ashworth Scale (MAS)
• Patients with a Brunnstrom stage of the lower extremity greater than 2
• Patients who are able to stand independently or under supervision for at least 2 minutes for standing assessments
• Patients who are able to walk at least 10 meters independently or under supervision, with or without an assistive device, for walking assessments
• Patients with sufficient cognitive function to understand study instructions (Mini-Mental State Examination \[MMSE\] score > 23)
• Patients with stable medical and psychological conditions
• Patients who are willing to participate in the study

Критерии исключения

• Patients with bilateral hemispheric lesions
• Patients with severe cardiovascular or musculoskeletal conditions that prevent walking (e.g., fixed ankle contracture)
• Patients using a permanent urinary catheter, or those with pressure ulcers or urinary and/or fecal incontinence
• Patients with unilateral neglect
• Patients with neurological conditions other than stroke that may affect balance performance (e.g., Parkinson's disease, epilepsy, meningitis, cerebellar disorders, vertigo, dizziness, polyneuropathy) or musculoskeletal disorders (e.g., severe low back pain, knee disorders)
• Patients with severe visual, hearing, or speech impairments

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

• Ankara, Çankaya, Türkiye (Türkiye), 06800 Gaziler Physical Medicine and Rehabilitation Tra — Ankara

Идентификаторы

NCT: NCT07550270 · E2-25-13626

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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