Välimäki Maritta, Korkeila Jyrki, Kauppi Kaisa, Kaakinen Johanna K, Holm Suvi, Vahlo Jukka, Tenovuo Olli, Hämäläinen Heikki, Sarajuuri Jaana, Rantanen Pekka, Orenius Tage, Koponen Aki
Faculty of Medicine, Department of Nursing Science, University of Turku, Finland.
JMIR Res Protoc. 2016 Feb 9;5(1):e6. doi: 10.2196/resprot.4841.
Traumatic brain injury (TBI) is a critical public health problem. The recovery process for people with TBI is typically slow and dependent on complex and intensive assisted rehabilitation programs.
To evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury.
This is a single-site feasibility study conducted in Finland, which uses a pragmatic, randomized controlled trial with three arms, and will recruit patients from the Turku University Hospital, Division of Clinical Neurosciences in Finland. Participants must meet the following inclusion criteria: (1) a Finnish speaking adult, aged 18-65 years; (2) diagnosed with a traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5) in the University Hospital; (3) access to a TV, a computer, and the Internet at home; (4) not an active digital gamer (5 hours or less a week); (5) willing to participate in the study. Participants must have been discharged from the neurologic treatment period for traumatic brain injury for over 12 months before the commencement of the trial, and they may not have actively participated in cognitive rehabilitation during the 3 months prior to the trial. Written informed consent will be mandatory for acceptance into the trial. Exclusion criteria are as follows: (1) sensory, cognitive, or physical impairment (eg, severe cognitive impairment); (2) a deficiency restricting the use of computers or computer game control system unaided (eg, impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system); (3) apathy identified in previous neuropsychological evaluations; (4) diagnosed severe mental disorders (eg, schizophrenia or severe depressive disorders to be identified in medical records as the secondary diagnosis).
The preparatory phase for the study is fulfilled. Recruitment started in June 2015 and finished November 2015. Results will be reported in 2016.
The specific outcomes such as primary outcome measures were selected because they are widely used psychological tests and thought to be sensitive to changes in the cognitive functions related to TBI.
Clinicaltrials.gov NCT02425527; https://clinicaltrials.gov/ct2/show/NCT02425527 (Archived by WebCite at http://www.webcitation.org/6esKI1uDH).
创伤性脑损伤（TBI）是一个严重的公共卫生问题。创伤性脑损伤患者的康复过程通常较为缓慢，且依赖于复杂且密集的辅助康复项目。
评估数字游戏对创伤性脑损伤患者认知功能和总体幸福感的影响及可行性。
这是一项在芬兰进行的单中心可行性研究，采用实用的三臂随机对照试验，将从芬兰图尔库大学医院临床神经科学科招募患者。参与者必须符合以下纳入标准：（1）年龄在18 - 65岁之间、讲芬兰语的成年人；（2）在大学医院被诊断为创伤性脑损伤（诊断标准ICD - 10，S06.X，T90.5）；（3）家中可使用电视、电脑和互联网；（4）不是活跃的数字游戏玩家（每周游戏时间5小时或更少）；（5）愿意参与研究。在试验开始前，参与者必须已从创伤性脑损伤的神经治疗期出院超过12个月，且在试验前3个月内未积极参与认知康复。进入试验必须获得书面知情同意。排除标准如下：（1）感觉、认知或身体损伤（如严重认知障碍）；（2）存在限制独立使用电脑或电脑游戏控制系统的缺陷（如视力损伤、严重散光、偏瘫、视觉空间感知障碍、中枢前庭系统功能障碍）；（3）在先前神经心理学评估中发现的冷漠；（4）被诊断为严重精神障碍（如精神分裂症或严重抑郁症，在病历中作为次要诊断被识别）。
该研究的准备阶段已完成。招募工作于2015年6月开始，2015年11月结束。结果将于2016年报告。
之所以选择诸如主要结局指标等特定结局，是因为它们是广泛使用的心理测试，并且被认为对与创伤性脑损伤相关的认知功能变化敏感。
Clinicaltrials.gov NCT02425527；https://clinicaltrials.gov/ct2/show/NCT02425527（由WebCite存档于http://www.webcitation.org/6esKI1uDH）
