Implementation of iDETECT for Field Triage of mTBI in Football Players
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion
研究概览
简要总结
The purpose of this study is to assess a new screening tool for sideline evaluation of concussion injuries in athletes. iDETECT is a new technology that combines several elements of recommended concussion screening tools into a single, portable device.
详细描述
The goal of the research is to evaluate the use of a multimodal platform (iDETECT) for immediate post-injury neuropsychological, balance and oculomotor assessment, and to evaluate the iDETECT platform as a return-to-play assessment tool during the post injury management period following concussion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Athletes participating in the Fall 2015 high school season
- •Aged 14 years or older
- •No concussion injuries within prior 2 months
- •Provide signed and data consent and/or assent form(s)
排除标准
- •Non-English speaking
- •History of seizures or prior brain surgery (excluding facial and TM surgery)
- •Concussion within last 2 months
- •Poor Effort on baseline iDETECT test
- •Non-Collision Sport Group
- •current concussion or history of current concussion during the Fall 2015 athletic season
结局指标
主要结局
Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for total score of NP will be computed and compared with the trainer's determination of clinical concussion to find out if iDETECT is as accurate in diagnosing concussion.
Area under the curve (AUC) for iDetect NP total score compared to the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for total score of NP will be computed and compared to the ImPACT score to find out if iDETECT is as accurate in diagnosing concussion.
Area under the curve (AUC) for iDetect NP response time to stimuli compared to the trainer's determination of clinical concussion
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for NP response will be computed and compared trainer's determination of clinical concussion to find out if iDETECT is as accurate in diagnosing concussion.
Area under the curve (AUC) for iDETECT total score compared to final clinical determination of concussion
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for iDETECT total score will be compared to the trainer's final clinical determination of concussion.
Area under the curve (AUC) for iDETECT total score compared to the Sport Concussion Assessment Tool (SCAT3)
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for iDETECT total score will be compared to the SCAT 3 score. SCAT3 is a standardized tool for evaluating injured athletes for concussion.
Area under the curve (AUC) for iDetect NP response time to stimuli compared to Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
时间窗: Baseline, throughout duration of sport season (an expected average of 4 months)
The area under the receiver operator characteristic (ROC) curve (the concordance index) for NP response will be computed and compared the ImPACT score to find out if iDETECT is as accurate in diagnosing concussion.
次要结局
- Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery time to balance compared to trainer's determination of clinical concussion(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery time to balance compared to Balance Error Scoring System (BESS) score(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery number of overshoots compared to BESS score(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion prediction compared to trainer's determination of clinical concussion(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion prediction compared to King-Devick score (time and number of errors)(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion interefence compared to trainer's determination of clinical concussion(Baseline, throughout duration of sport season (an expected average of 4 months))
- Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion interefence compared to King-Devick score (time and number of errors)(Baseline, throughout duration of sport season (an expected average of 4 months))
- Change in iDETECT total score from baseline to time of injury(Baseline, time of concussion)
- Change in iDETECT total score from baseline to end of season to assess subconcussion(Baseline, end of sport season (an expected average of 4 months))
- Change in Sport Concussion Assessment Tool 3 (SCAT3) total score from baseline to end of season to assess subconcussion(Baseline, end of sport season (an expected average of 4 months))
- iDETECT word recall score post injury(3 days post injury (3 minutes))
- Change in iDETECT mean word recall score post injury, 10 days(3 days post injury (3 minutes), 10 days post injury (3 minutes))
- Change in iDETECT mean word recall score post injury, 30 days(10 days post injury (3 minutes), 30 days post injury (3 minutes))
- iDETECT shapes test score post injury(3 days post injury (2 minutes))
- Change in iDETECT mean shapes test score post injury, 10 days(3 days post injury (2 minutes), 10 days post injury (2 minutes))
- Change in iDETECT mean shapes test score post injury, 30 days(10 days post injury (3 minutes), 30 days post injury (3 minutes))
- iDETECT arrows test score post injury(3 days post injury (2 minutes))
- Change in iDETECT mean arrows test score post injury, 10 days(3 days post injury (2 minutes), 10 days post injury (2 minutes))
- Change in iDETECT mean arrows test score post injury, 30 days(10 days post injury (2 minutes), 30 days post injury (2 minutes))
- iDETECT N-BACK (1-back and 2-back) test post injury(3 days post injury (2 minutes))
- iDETECT Delayed Word Recall Test(3 days post injury (2 minutes))
- Change in iDETECT Delayed Word Recall Test(10 days post injury (2 minutes), 30 days post injury (2 minutes))
研究者
Tamara Espinoza, MD
Assistant Professor
Emory University