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临床试验/NCT03230656
NCT03230656已完成不适用

Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury

Northern Arizona University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
RBMT-3 Story Immediate and Delayed Recall

研究概览

简要总结

Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems identified by these patients include difficulty with memory, multi-tasking, the ability to complete tasks quickly, and higher executive functions (e.g., inhibition, initiation, insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing) (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both thinking and communication can better identify individuals at-risk for persistent symptoms at two week and four weeks post-injury. Also, if cognitive-communication therapy was administered earlier post-injury, then outcomes related to return to daily activities, work, and/or the academic setting could possibly change. This study intends to investigate the use of cognitive and communication screening measures for the identification of persistent symptoms and the provision of early cognitive-communication therapy if problems persist.

详细描述

Approximately 15-20% of patients with concussion/mild traumatic brain injury (mTBI) have persistent cognitive symptoms up to six months or longer. Problems with working memory, divided attention, processing speed, and executive function are common (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). Patients often report how these problems negatively impact daily communication. Although neurocognitive tests are frequently used to identify patients at-risk for persistent symptoms, perhaps tests that not only assess cognition, but also communication would be better at identifying more functional deficits. Patients at-risk for persistent symptoms could then begin therapy earlier to address problems affecting work, school, or everyday activities. Speech-language pathologists are uniquely qualified to evaluate and treat patients with concussion/mTBI and cognitive-communication disorders (ASHA, 2005; Cicerone, et al.; Cornis-Pop et al., 2012). Cognitive-communication is the relationship between cognition and its influence on verbal and nonverbal communication, reading, and writing (ASHA, 2007). At this time, practice guidelines are emerging for cognitive-communication intervention related to concussion/mTBI (Cornis-Pop et al., 2012), yet there is still much research to be done. Typically, in recovery following a concussion/mTBI, patients are referred for cognitive-communication intervention if they are failing or struggling at work, school, or in daily activities. Some patients will not be seen for up to six months based on the assumption by healthcare professionals that most persistent cognitive and communication symptoms will resolve on their own. The wait period before referral for additional services is currently being investigated in the literature. Additionally, therapy for cognitive-communication will only be provided if patients report difficulties to their physicians and are referred for services. If services are not sought out, problems in cognitive-communication will go unrecognized as being a result of the concussion/mTBI.

The specific aims of this study are: 1) Determine if screening measures that evaluate symptoms of concussion/mTBI frequently used by speech-language pathologists administered two and four weeks post-injury will be able to predict individuals at-risk for persistent cognitive and communication symptoms, and 2) Will an early treatment group with persistent cognitive-communication deficits one month after injury differ in pre- and post-therapy functional outcome measure scores as compared to a delayed therapy group beginning services at two months post-injury?

Significance: Results of this study will increase the understanding in the use of cognitive and communication screening measures frequently administered by speech-language pathologists to identify patients at-risk for persistent symptoms related to concussion/mTBI and provide information about the outcomes of cognitive-communication intervention delivered early in recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
None

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
否

入选标准

  • •diagnosed with concussion/mTBI by ER physician
  • •speak English as the primary language
  • •have functional hearing and vision to take the screening measures
  • •have no prior history of a TBI requiring hospitalization and/or rehabilitation
  • •have no history of other neurological or psychological diagnoses that would prevent the completion of the screening measures
  • •mild to moderate hearing loss with aided amplification
  • •reading glasses to correct their vision
  • •bilingual subjects whose primary language is English will be included

排除标准

  • •do not live in Flagstaff, AZ or the surrounding area making them unavailable for follow-up screening or therapy
  • •English is not spoken as the primary language
  • •have severe hearing loss or vision problems which cannot be corrected with hearing aids or glasses
  • •prior history of a traumatic brain injury requiring hospitalization and/or rehabilitation
  • •history of other neurological or psychological diagnoses preventing the completion of the screening sessions

研究组 & 干预措施

Early therapy 1 month post-injury

Experimental

Early cognitive-communication therapy 1 month post-injury:

  • working memory strategies
  • executive function program
  • divided attention program
  • environmental changes
  • identification of problematic cognitive-communication situations

干预措施: Early cognitive-communication therapy (Other)

Waitlist therapy 2 months post-injury

Active Comparator

Waitlist early cognitive-communication therapy 2 months post injury:

- Same cognitive-communication therapy is administered

干预措施: Early cognitive-communication therapy (Other)

结局指标

主要结局

RBMT-3 Story Immediate and Delayed Recall

时间窗: 15

Assesses working memory and verbal language

SCAN-A Competing Sentences Subtest

时间窗: 20 minutes

Assesses working memory, divided attention, and verbal language

WJ-III Tests of Cognitive Abilities Matching subtest

时间窗: 3 minutes

Evaluates speed of processing

FAVRES Sequencing subtest

时间窗: 20 minutes

Evaluates executive function, verbal language, reading, and writing,

次要结局

  • Functional outcome measure(40 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emi Isaki

Associate Professor

Northern Arizona University

研究点 (1)

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