Effect of Cognitive Rehabilitation Using Immersive Virtual Reality on Cognitive Function and Functional Activity of Subacute Stroke Patients: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA)
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the effectiveness of cognitive rehabilitation using an immersive Virtual Reality (VR) system compared to conventional paper-and-pencil cognitive training in subacute stroke patients. A total of 22 participants will be randomly assigned to either the VR intervention group (n=11) or the conventional control group (n=11). The study will measure changes in cognitive function and functional independence
详细描述
Cognitive impairment is a common and debilitating consequence of stroke that hinders functional recovery. This pilot study investigates immersive Virtual Reality (VR) as a novel, engaging modality for cognitive rehabilitation in subacute stroke patients.
Twenty-two eligible subacute stroke patients treated at Dr. Hasan Sadikin General Hospital will be recruited and randomized into two parallel arms. The experimental group (n=11) will receive cognitive rehabilitation using an immersive VR system, while the active control group (n=11) will receive conventional cognitive rehabilitation using standardized paper-and-pencil tests. Both interventions will be administered alongside standard stroke rehabilitation care. Assessments will be conducted at baseline and post-intervention to evaluate cognitive improvement using the Indonesian version of the Montreal Cognitive Assessment (MoCA-INA) and functional activity using the Functional Independence Measure (FIM).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 40-59 years old
- •Stroke patient 2-4 months onset of stroke
- •Burnstorm stage V or above
- •First-time stroke that has been diagnosed by a neurologist with CT scan and/or MRI
- •Stroke risk factors and comorbidities are controlled with medication
- •Mild and moderate level of cognitive impairment based on MOCA and can use devices
- •Participants can grip and operate VR console with their hand
- •Participants can follow instructions and exercises
- •Participants were cooperative and willing to participate in the study by signing a consent form after receiving an explanation.
排除标准
- •Participants with severe cognitive impairment or aphasia struggle to understand instructions
- •Neglected patient
- •Participants with low vision unable to perceive content on screens
- •Participant with eyestrain characterized by blurring vision, dry eyes, foreign body sensation, itching watering, neck stiffness and backache
- •Severe musculoskeletal disorders causing problem in standing and following instruction
研究组 & 干预措施
Experimental: Immersive VR Cognitive Rehabilitation
articipants in this group (n=11) will receive cognitive rehabilitation sessions using an immersive Virtual Reality (VR) headset and software, in addition to standard stroke care
干预措施: Immersive Virtual Reality System (Device)
Active Comparator: Conventional Cognitive Rehabilitation
Participants in this group (n=11) will receive standard cognitive rehabilitation using conventional paper-and-pencil tasks, in addition to standard stroke care.
干预措施: Conventional Paper-and-Pencil Cognitive Training (Behavioral)
结局指标
主要结局
Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA)
时间窗: Baseline and Post-Intervention (Week 8)
The MoCA-INA assesses several cognitive domains including visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered normal.
Change in Functional Activity Assessed by Functional Independence Measure (FIM)
时间窗: Baseline and Post-Intervention (Week 8)
The FIM is an 18-item measurement tool that explores an individual's physical, psychological, and social function. The tool assesses the level of independence a patient has in daily tasks. Total scores range from 18 to 126, with higher scores indicating a higher level of functional independence
次要结局
未报告次要终点