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临床试验/NCT03558308
NCT03558308已完成不适用

The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study

Katrine Sværke2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年8月1日最近更新:
适应症

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
2
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

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

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)
  • Digit span (WAIS-IV)(5 minutes)
  • Stroop colour and word test(3 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

发起方
Katrine Sværke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Katrine Sværke

Bsc. Psychology

Bispebjerg Hospital

研究点 (2)

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