Smart Autonomous Neuro-Rehabilitation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Change in Corsi block tapping test from baseline to end of treatment and to follow-up
研究概览
简要总结
Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score on Mini-Mental State Examination between 18 - 24
- •Score on Montreal Cognitive Assessment less than 26
- •More than 2 points in upper limb motor scale MRC
- •Sufficient cognitive ability to understand and follow the experimental instructions
排除标准
- •Score on Mini-Mental State Examination below 18 or above 24
- •Score on Montreal Cognitive Assessment of 26 or above
- •Below 2 point in upper limb motor scale MRC
- •Hemianopia
- •Cognitive capacity that prohibits the execution of the experiment
- •Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment
- •History of serious mental-health problems in acute or subacute phase
- •Patients that do not give their consent to participate in the study
研究组 & 干预措施
Cognitive rehabilitation group
Cognitive rehabilitation training with RGS in the clinic.
干预措施: Cognitive rehabilitation training with RGS in the clinic (Behavioral)
Passive control group
Passive/conventional cognitive training at home.
干预措施: Passive/conventional cognitive training at home. (Behavioral)
结局指标
主要结局
Change in Corsi block tapping test from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of attention
Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of episodic memory
Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of executive functioning
Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of processing speed
Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of set-shifting
Change in Star Cancellation test from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of spatial neglect
Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of working memory
Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of attention
Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of attention
Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up
时间窗: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)
Measurement of working memory
次要结局
- Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up(Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
- Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up(Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
- Change in Barthel Index from baseline to end of treatment and to follow-up(Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
- Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up(Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
研究者
Paul Verschure
PhD
Universitat Pompeu Fabra