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临床试验/NCT02719964
NCT02719964Unknown不适用

Rehabilitation of Visual Attention Following mTBI

United States Naval Medical Center, San Diego2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Severity of Post-Concussive Symptoms

研究概览

简要总结

The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual attention deficits in U.S. military service members across three programs: Visual Attention and Working Memory Programs (UCR Games), Speech Pathologist-Directed Treatment, and General Cognitive Rehabilitation Games (Lumosity).

In addition to the above prospective component, this study also has a retrospective component in which archival data collected from routine clinical care will be examined for analysis. The investigators hope to gain a better understanding of the unique and cumulative influence different cognitive rehabilitation programs have on improving attention complaints in mTBI.

详细描述

Mild traumatic brain injury (mTBI) is one of the most commonly sustained combat-related injuries. Complaints of poor attention often follow mTBI and can become chronic in some individuals. Chronic attention complaints have traditionally been treated with cognitive rehabilitation by speech pathologists. Recent research has shown that computerized programs may add additional value either independently or in conjunction with traditional therapies. Researchers at UC Riverside have already completed research showing that vision training, using the ULTIMEYES program that they created, led to improved vision both on standard assessments, such as reading eye-charts, and in real world skills, such as reading and playing baseball. This program is designed to broadly improve basic aspects of vision, such as visual acuity and contrast sensitivity, as well as high-level vision, such as attention. Furthermore, an associated memory training task (Recall The Game) shows improvements in memory tasks and transfer to skills such as fluid intelligence.

The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual attention deficits in U.S. military service members across three programs:

  1. Visual Attention and Memory Program (UCR Games)
  2. Cognitive and Psychological Based Rehabilitation (Speech Pathologist-Directed Therapy)
  3. General Cognitive Rehabilitation Games (Lumosity [2])

The investigators hope to gain a better understanding of the unique and cumulative influence of different cognitive rehabilitation programs on improving attention complaints in mTBI. This proposal contains both retrospective and prospective components.

The retrospective component consists of examining archival data from Lumosity, previously collected as part of routine clinical care. The data contain pre- and post-assessments of post-concussive symptoms, symptom frequency, and cognitive testing. The investigators expect that data analysis will reveal evidence of improvement in severity of post-concussive symptoms, in frequency of troublesome cognitive problems, and in performance on neuropsychological tests when pre- and post-assessments are compared.

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 (Participant)

入排标准

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

入选标准

  • Closed TBI
  • Have sufficient information available that we can confidently classify severity as mild based on DOD/VA criteria
  • Time tested post-injury > 3 months
  • Ongoing attention complaints

排除标准

  • Moderate/Severe TBI
  • Penetrating TBI
  • Attention Deficit Hyperactivity Disorder
  • Learning Disorder
  • Diagnosed medical condition that is expected to impact cognitive performance (i.e. Multiple Sclerosis, Stroke)

研究组 & 干预措施

A: UCR Games→SP-Directed Therapy

Experimental

Participants in Arm A will first participate in Visual Attention Program (UCR Games) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment intervention.

干预措施: Visual Attention Program (UCR Games) (Other)

A: UCR Games→SP-Directed Therapy

Experimental

Participants in Arm A will first participate in Visual Attention Program (UCR Games) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment intervention.

干预措施: Speech Pathologist-Directed Therapy (Other)

B: Lumosity→SP-Directed Therapy

Experimental

Participants in Arm B will first participate in General Cognitive Rehabilitation Games (Lumosity) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment intervention.

干预措施: Speech Pathologist-Directed Therapy (Other)

B: Lumosity→SP-Directed Therapy

Experimental

Participants in Arm B will first participate in General Cognitive Rehabilitation Games (Lumosity) followed by Speech Pathologist-Directed Therapy with assessment sessions prior to and following each treatment intervention.

干预措施: General Cognitive Rehabilitation Games (Lumosity) (Other)

C: SP-Directed Therapy→UCR Games

Experimental

Participants in Arm C will first participate in Speech Pathologist-Directed Therapy followed by Visual Attention Program (UCR Games) with assessment sessions prior to and following each treatment intervention.

干预措施: Visual Attention Program (UCR Games) (Other)

C: SP-Directed Therapy→UCR Games

Experimental

Participants in Arm C will first participate in Speech Pathologist-Directed Therapy followed by Visual Attention Program (UCR Games) with assessment sessions prior to and following each treatment intervention.

干预措施: Speech Pathologist-Directed Therapy (Other)

D: SP-Directed Therapy→Lumosity

Experimental

Participants in Arm D will first participate in Speech Pathologist-Directed Therapy followed by General Cognitive Rehabilitation Games (Lumosity) with assessment sessions prior to and following each treatment intervention.

干预措施: Speech Pathologist-Directed Therapy (Other)

D: SP-Directed Therapy→Lumosity

Experimental

Participants in Arm D will first participate in Speech Pathologist-Directed Therapy followed by General Cognitive Rehabilitation Games (Lumosity) with assessment sessions prior to and following each treatment intervention.

干预措施: General Cognitive Rehabilitation Games (Lumosity) (Other)

结局指标

主要结局

Severity of Post-Concussive Symptoms

时间窗: Two Months

Comparison of self-reported symptoms on pre- and post-intervention assessment.

Post-Concussion Cognitive Symptoms

时间窗: Two Months

Comparison of performance on pre- and post-intervention neuropsychological testing battery.

次要结局

未报告次要终点

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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