Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Qualitative Gait Assessment
研究概览
简要总结
The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction.
The main questions this study aims to answer are:
- Does immersive virtual reality combined with stationary cycling improve gait compared with neurological physiotherapy alone?
- Does this combined intervention improve balance, coordination, motor function, and muscle tone in individuals with stroke?
- How do participants and therapists perceive the use of immersive virtual reality combined with stationary cycling during rehabilitation?
Researchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone.
Participants will:
- Take part in two intervention periods, with a total of 16 sessions over 8 weeks (two sessions per week).
- Receive intervention sessions that include immersive virtual reality combined with stationary cycling and neurological physiotherapy, or neurological physiotherapy alone, depending on the intervention period.
- Complete assessments of gait, balance, and motor function at baseline, after the first intervention period, and after the second intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years or older with a medically documented diagnosis of hemorrhagic or ischemic stroke.
- •At least 6 months post-stroke.
- •Presence of hemiparesis.
- •Mild to moderate balance impairment, defined as a Berg Balance Scale score <
- •Gait impairment, defined as a Wisconsin Gait Scale score >
- •Preserved active movement in the lower limbs and ability to mount and remain seated on the stationary bicycle.
排除标准
- •Severe cardiac conditions.
- •Visual or auditory impairments limiting the use of virtual reality head-mounted displays.
- •Medical history of epilepsy.
- •Severe attentional impairment or inability to cooperate with the study intervention.
- •Severe cognitive impairment and marked difficulties in comprehension.
- •Severe vestibular disorders and predisposition to dizziness or vomiting.
研究组 & 干预措施
Neurological Physiotherapy (Group A)
The neurological physiotherapy group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided.
干预措施: Neurological Physiotherapy intervention (NP). (Other)
Neurological Physiotherapy (Group A)
The neurological physiotherapy group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided.
干预措施: Virtual Reality Combined with Stationary Cycling intervention (VR-SC) (Device)
Virtual Reality Combined with Stationary Cycling (Group B)
Virtual Reality Combined with Stationary Cycling group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided.
干预措施: Neurological Physiotherapy intervention (NP). (Other)
Virtual Reality Combined with Stationary Cycling (Group B)
Virtual Reality Combined with Stationary Cycling group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided.
干预措施: Virtual Reality Combined with Stationary Cycling intervention (VR-SC) (Device)
结局指标
主要结局
Qualitative Gait Assessment
时间窗: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
The outcome measures will include the Wisconsin Gait Scale (WGS) for qualitative gait assessment. The Wisconsin Gait Scale consists of 14 observable items that analyze gait components. Each item is scored from 1 (normal) to 3 (atypical), except for item 1 (scored from 1 to 5) and item 11 (scored from 1 to 4). Total scores range from 13.35 to 42, with higher scores indicating greater gait impairment.
Quantitative Gait Assessment
时间窗: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
The outcome measures will include the 6-Minute Walk Test (6MWT) for quantitative gait assessment. The 6-Minute Walk Test measures the total distance in meters that the participant can walk within six minutes. The test is performed on a 30-meter course marked by two cones, with a chair available for rest if needed.
次要结局
- Balance(The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).)
- Motor Function(The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).)
- Spasticity(The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).)