Effects of Virtual Reality-Enhanced Rehabilitation on Cognitive Recovery in Acute Post-Stroke Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The Mini-Mental State Examination (MMSE)
研究概览
简要总结
Post-stroke rehabilitation is essential for maximising the recovery of cognitive function. Virtual reality (VR) has emerged as a promising adjunct to conventional rehabilitation therapy (CRT), with the potential to enhance cognitive performance outcomes. This study aims to evaluate the effects of VR-based rehabilitation compared with CRT on cognitive function and activities of daily living in patients with acute stroke.
详细描述
The investigators will conduct a prospective randomised single- blind pilot controlled trial to evaluate the efficacy of VR-based rehabilitation with the Bimeo PRO system on cognitive function and activities of daily living in patients with acute stroke. Participants will be randomly assigned to a two-week VR training program combined with conventional therapy (experimental group) or to conventional therapy alone (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Therapists who will evaluate participants with scales will be blinded to group allocation.
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
- •Adults ≥18 years.
- •First-ever acute stroke, occurring <7 days before therapy start
- •Cognitive impairment on admission (Mini-Mental State Examination score < 24
- •Ability to understand and perform virtual reality (VR) tasks.
排除标准
- •Severe cognitive impairment that precludes following instructions.
- •Aphasia or severe visual/hearing impairment that prevents meaningful participation.
- •End-stage/terminal illness.
研究组 & 干预措施
VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy)
The experimental group will receive physiotherapy and occupational therapy (manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training such as horizontally moving an object across a surface), ten sessions over two weeks of 60 minutes per session and an additional 15 minutes of virtual-reality (VR) training per session using the Bimeo PRO system (Kinestica d.o.o., Slovenia) in a unimanual, two-dimensional configuration on a flat surface, with continuous therapist supervision.
干预措施: Virtual reality-enhanced rehabilitation (Behavioral)
VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy)
The experimental group will receive physiotherapy and occupational therapy (manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training such as horizontally moving an object across a surface), ten sessions over two weeks of 60 minutes per session and an additional 15 minutes of virtual-reality (VR) training per session using the Bimeo PRO system (Kinestica d.o.o., Slovenia) in a unimanual, two-dimensional configuration on a flat surface, with continuous therapist supervision.
干预措施: Conventional rehabilitation therapy (CRT) (Other)
CRT (Conventional rehabilitation therapy)
The control group will receive 10 sessions over 2 weeks of physiotherapy and occupational therapy (manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training, such as moving an object horizontally across a surface), each lasting 60 minutes.
干预措施: Conventional rehabilitation therapy (CRT) (Other)
结局指标
主要结局
The Mini-Mental State Examination (MMSE)
时间窗: Change from baseline to 2 weeks (end of intervention)
It is a widely used screening tool for global cognitive function. It evaluates orientation, immediate registration and short-term recall, attention and calculation, and language and praxis. The total score ranges from 0 to 30, and scores below 24 are commonly interpreted as suggestive of cognitive impairment.
The Barthel Index (BI)
时间窗: Change from baseline to 2 weeks (end of intervention)
The Barthel Index (BI) evaluates an individual's level of independence and mobility in activities of daily living (ADLs), including feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, walking/ambulation, and stair climbing. It also helps determine the degree of assistance required for care.
次要结局
- The National Institutes of Health Stroke Scale (NIHSS)(Change from baseline to 2 weeks (end of intervention))
- The Modified Rankin Scale (mRS)(Change from baseline to 2 weeks (end of intervention))
研究者
Tadeja Hernja Rumpf
Principal Investigator
University Medical Centre Maribor