Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- VR-based EF Assessment Task
研究概览
简要总结
Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable. In this study, the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood TBI.
详细描述
Traumatic brain injury (TBI) is a leading cause of acquired disability in U.S. children, with an estimated 700,000 cases every year, presenting in 75% of children with trauma and accounting for 70% of deaths from childhood trauma. Childhood TBIs often result in significant impairment in cognitive functions,1 particularly in core executive functions (EFs) due to the vulnerability of the frontal lobes, especially after a moderate to severe TBI. Core EF is composed of three skills: inhibitory control, working memory, and cognitive flexibility. These skills are associated with impaired EF behaviors, increased attention problems, and lower health-related quality-of-life (HRQOL). However, evidence-based EF rehabilitation programs are lacking. Although a combination of diverse cognitive interventions may improve children's EF, limited affordability, accessibility, adherence, and generalizability hamper clinically adapting and implementing such interventions in the rehabilitation setting. Virtual reality (VR) offers an exciting alternative strategy for EF rehabilitation of childhood TBI due to its flexibility, accessibility, and immersive experiences in three dimensions. These properties may increase adherence to training and foster an enhanced transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigor-ous randomized clinical trials (RCTs) have not been conducted to establish the efficacy of VR-based EF reha-bilitation for childhood TBI.
The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training (VICT) program for EF rehabilitation in children with TBI with the following aims:
Aim 1. Examine VICT's efficacy in improving core and daily EF skills among children with TBI.
Hypothesis 1.1: Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits; Hypothesis 1.2: The intervention group will show better reported daily EF than controls at the follow-up visit; Hypothesis 1.3: Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits.
Aim 2. Examine VICT's efficacy in reducing attentional problems among children with TBI.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with TBI within the past 12 months and under 18 years at the time of injury;
- •fluent in English; and 3) Score <28 on the Agitated Behavior Scale (if available).
排除标准
- •comorbidities or premorbid disorders that prevent proper administration of VR and study measures,
- •restriction from using electronic devices,
- •post-injury seizure activity.
结局指标
主要结局
VR-based EF Assessment Task
时间窗: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.
次要结局
- NIH Toolbox Cognition Battery(Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention))
- Report-based EF Skills(Follow-Up (up to 6 months after completion of intervention))
- Health-related Quality of Life(Follow-Up (up to 6 months after completion of intervention))
研究者
Jiabin Shen, PhD
Assistant Professor, Psychology
University of Massachusetts, Lowell