The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Trail making test A+B
研究概览
简要总结
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury
详细描述
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. Furthermore, the study consists of Groups that receives the computerized training both with and witouth support from a professional.
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 (Participant, Outcomes Assessor)
盲法说明
Patients know that one of the conditions is a control-condition not expected to have significant clinical effects (required by the danish scientific committee), but they don't know which treatment condition they are randomised to. The outcome assessor is blind to the group allocation of patients.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who are able to give an informed consent both verbally and in writing
- •Persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset)
- •Persons who score less than the
- •Percentile in one or more of the primary outcome measures outlined above.
排除标准
- •Persons with neurodegenerative diseases
- •Persons with diseases which can influence executive functions such as ADHD
- •Persons who are motorically or cognitively unable to use a tablet and complete the CBCR-training
研究组 & 干预措施
Brain+ with clinical support
Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period.
干预措施: Computer based cognitive rehabilitation (Behavioral)
Cogmed with continuous support
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period.
干预措施: Computer based cognitive rehabilitation (Behavioral)
Brain+ without support
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period.
干预措施: Computer based cognitive rehabilitation (Behavioral)
Sham-training group
Intervention: Sham computerized gaming. This group will train computerized solitaire and other computerized games which are thought to be generally cognitive stimulating but with a very limit load on executive functions. This group will receive continuous support during the intervention period.
干预措施: Sham computerized gaming (Other)
结局指标
主要结局
Trail making test A+B
时间窗: 5 minutes
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts
PASAT
时间窗: 3 seconds
Paced auditory serial addition test, test of verbal working memory
次要结局
- Word fluency test(1 min)
- Stroop colour and word test(3 minutes)
- Digit span (WAIS-IV)(5 minutes)
- Quality of Life after Brain Injury (QOLIBRI)(10 minutes)
- Spatial span (WMS-III)(5 minutes)
- BNI-FS(10 minutes)
- Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(10 minutes)
- SDMT(90 seconds)
研究者
Katrine Sværke
Bsc. Psychology
Bispebjerg Hospital