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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 10-Meter Walk Test
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality-Assisted Forward Gait Training
Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported virtual reality-assisted forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day).
干预措施: Virtual Reality-Assisted Gait Training (Other)
Backward Gait Training
Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported backward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day).
干预措施: Backward Gait Training (Other)
Forward Gait Training
Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day).
干预措施: Forward Gait Training (Other)
结局指标
主要结局
10-Meter Walk Test
时间窗: At baseline and after 6 weeks of intervention.
A measure used to assess patients' ambulation. During the test, the patient walks at a comfortable walking speed between two markers placed 10 meters apart, and the time required to complete the distance is recorded.
次要结局
- 6-Minute Walk Test (6MWT)(At baseline and after 6 weeks of intervention)
- Fugl-Meyer Assessment - Lower Extremity Motor Subscale(At baseline and after 6 weeks of intervention)
- Functional Independence Measure (FIM)(At baseline and after 6 weeks of intervention.)
- Berg Balance Scale (BBS)(At baseline and after 6 weeks of intervention.)
- Montreal Cognitive Assessment (MoCA)(At baseline and after 6 weeks of intervention.)
- Stroke-Specific Quality of Life Scale (SS-QOL)(At baseline and after 6 weeks of intervention.)
- Hospital Anxiety and Depression Scale (HADS)(At baseline and after 6 weeks of intervention.)
- Foot Rotation(At baseline and after 6 weeks of intervention.)
- Step Width(At baseline and after 6 weeks of intervention.)
- Step Length(At baseline and after 6 weeks of intervention.)
- Stance Phase(At baseline and after 6 weeks of intervention.)
- Swing Phase(At baseline and after 6 weeks of intervention.)
- Double Stance(At baseline and after 6 weeks of intervention.)
- Gait Velocity(At baseline and after 6 weeks of intervention.)
- Cadence(At baseline and after 6 weeks of intervention.)
- Maximum Plantar Pressure(At baseline and after 6 weeks of intervention.)
- Center of Pressure, Lateral Symmetry(At baseline and after 6 weeks of intervention.)
研究者
Tuğba Atan, MD
Tugba Atan, MD, Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital