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临床试验/NCT05443542
NCT05443542招募中不适用

Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury

Sunnaas Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Change in processing speed

研究概览

简要总结

One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.

详细描述

A randomized controlled trial (RCT) will be conducted where the experimental intervention is playing a commercial VR game. The VR group will follow a training regime of a 30 min VR session five times per week for 5 weeks. The control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. Baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (T1), at the end of the intervention period (T2) and at the 16-week follow-up (T3).

The VR group will train with a rhythm VR game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory.

The VR game is selected on the grounds of clinical experience with VR training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in stable phase after Acquired brain injury, minimum one year after injury
  • Physically able to operate VR-technology
  • Norwegian or English skills adequate to understand instructions, play the VR-games and to provide valid responses to assessment methods

排除标准

  • Severe aphasia affecting their understanding of instructions
  • Apraxia affecting their ability to use VR-equipment
  • Visual neglect
  • Severe mental illness, substance abuse or co-existing neurological disorders

结局指标

主要结局

Change in processing speed

时间窗: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

Connors Continous Performance test 3rd edition, Coefficient of Variation

次要结局

  • Change in working memory(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))
  • Change in patient reported executive functioning(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))
  • Change in informant reported executive functioning(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))
  • Change in sustained attention(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))
  • Transfer effect to everyday activities(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))

研究者

发起方
Sunnaas Rehabilitation Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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