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临床试验/NCT02753244
NCT02753244Unknown不适用

A Study to Assess the Feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury Patients and to Evaluate the Effects of Training on Their Cognitive Performance

Intendu Ltd.4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
4
主要终点
Change in Cognitive Functions

研究概览

简要总结

This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance

详细描述

This study includes three experimental arms to research cognitive video games involving motion interaction in ABI population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve a randomized controlled study with inpatient participants, where participants are randomly assigned to an intervention or control group. Recruitment phase includes cognitive assessments to evaluate eligibility for the study. In the assessment and post assessment phases cognitive performance is established.

Intervention includes 10 computerized training sessions of 30-45 minutes over 3 weeks period using Intendu Functional Brain Trainer (FBT). The control group intervention involves playing commercial iPad games for the same duration. Interventions will be performed in addition to standard inpatient treatment.

In addition to the randomized control study, a third experimental arm will be performed, were participants living in the community will perform a similar protocol with cognitive motion-based video games. The recruitment, assessment, post assessment and intervention phases will be similar to the above.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Acquired Brain Injury.
  • At least one functional upper limb.
  • Ability to understand instructions that will be assessed by the therapist.
  • Basic cognitive ability in Orientation, Visual Perception and Spatial Perception.
  • Impairment in Executive Functions (EF) as assessed by EF assessments.
  • normal vision.

排除标准

  • Untreated epilepsy
  • Other Psychiatric or Neurological disease.
  • Neglect or Hemianopia.
  • For the Community arm - doesn't receive any cognitive therapy.

结局指标

主要结局

Change in Cognitive Functions

时间窗: Week 0, week 4

Assessments of cognitive skills as they express in task performance.

Change in Cognitive Performance Questionnaires

时间窗: Week 0, week 4

Questionnaire assessing cognitive skills as they express in everyday function.

次要结局

  • Experience during intervention(week 4)
  • Safety - Record of any adverse event(Weeks 0-4)

研究者

发起方
Intendu Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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