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临床试验/NCT03309930
NCT03309930Unknown不适用

Narrative Comprehension by People With Acquired Brain Injury

Miami University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Comprehension Across Conditions (Study 1 of 2)

研究概览

简要总结

The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text and auditory output. The phase 2 portion of the study is to evaluate comprehension of sentences and paragraphs produced with computer generated (synthesized) speech and digitized natural speech after multiple exposures.

详细描述

Part 1 Experimental Procedures: Written or Spoken Paragraph Level Measure o Participants will read or listen to 12 paragraph length narrative stories in the following 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David), or combined written text and auditory output. Participants will answer 10 questions regarding the information contained in each of the 12 stories. Anticipated time requirements: 1 to 2 sessions lasting about 60 minutes each.

Part 2 Experimental Procedures: Repeated Exposures

  • Independent Training Session Practice

  • To prepare the participants for independent practice (exposure) to the Synthetic 1 Condition during home training, the researchers will complete the first Independent Training Session with the participant within the clinic environment to verify participants understanding of the experimental procedure.

  • The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.

  • Independent training sessions will utilize the Test of Silent Reading Efficiency and Comprehension (TOSREC) sentences recorded using the Synthetic 1 Voice Condition and the Digitized Voice Condition. TOSREC sentences are simple sentences presented at 1st, 2nd, and 3rd grade levels. Example sentence include: "A cow is an animal", and "Bears go to school". The participants will respond "yes" or "no" to each of 30 TOSREC sentences presented in a systematically randomized order. "Yes" and "no" responses will be recorded using active areas on the iPad created using a computer program designed for delivering stimuli (e.g., Blackboard, Canvas). All practice will be completed via the computer platform (e.g., Blackboard, Canvas) on the iPad. All 30 practice items should be completed in one sitting; however, the participant can take a break 5-10 minutes break during practice if needed.

  • During this first Independent Training Session Practice, the researcher will provide the participant with verbal and written instructions regarding how to access each item and ensure that the participant understands the task prior to independent practice.

  • Independent Training Sessions

  • Participants will be given an iPad with Wi-Fi capabilities to use in their home (as well as a charger. Alternatively, participants may choose to use their own iPad.

  • The researchers will instruct each participant to listen to and/or reading 15 sentences per day per condition (Synthetic 1 and Digitized Sentence presentations). The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.

  • The participants will respond "yes" or "no" to each of the 30 TOSREC sentences presented in a systematic randomized order. All 30 practice items should be completed in one sitting; however, the participant can take a 5-10 minute preach during practice if needed.

  • Participants will receive feedback about overall percentage performance accuracy at the end of each daily session.

  • All practice will be completed via the computer platform (e.g., Blackboard, CANVAS) on the iPad. Participants will practice for a period of two weeks (12 sessions). This is expected to take the participants no more than 15 minutes per day. The person will be asked to complete the practice up to 6 days per week. The participant will decide the days and times of practice as fits his or her schedule.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have a clinical diagnosis of an acquired cognitive-communication impairment secondary to brain injury/stroke
  • be 19-85 years of age
  • be a least, 3 months post acquired brain injury
  • primarily be a speaker of American English

排除标准

  • exhibit the presence of a hearing impairment (i.e., prescribed hearing aid or failed hearing screening)
  • demonstrate a vision or motor impairment that negatively influences study completion
  • Study 2: have not access to wireless internet
  • Study 2: exhibit and inability to independently (or with caregiver support) use the iPad device to complete the experimental tasks.

研究组 & 干预措施

Comprehension Acquired Brain Injury

Experimental

All participants will be exposed to 3 conditions: (a) written text, (b) auditory output (synthetic speech), and combined conditions for study 1. For study 2 participants will be repeatedly exposed to synthetic speech output to determine the influence on comprehension. Participants are not required to participate in both studies.

干预措施: Comprehension Acquired Brain Injury (Behavioral)

结局指标

主要结局

Comprehension Across Conditions (Study 1 of 2)

时间窗: Comprehension accuracy across conditions will be assessed over 1 to 2 days.

Participants will answer 10 multiple choice questions regarding the information contained in each of the 12 stories presented in 3 conditions: (1) written text only (b) auditory output only and (c) combined written text and auditory output .

Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2)

时间窗: 2 weeks

Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks

次要结局

  • Perceived Comprehension Accuracy(measured 1 week and 4 weeks post termination of treatment)
  • Comprehension Generalization(measured 1 week and 4 weeks post termination of treatment)

研究者

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

Kelly Knollman-Porter

Assistant Professor

Miami University

研究点 (2)

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