Traumatic Brain Injury Clinical Trial
Official title:
Narrative Comprehension by People With Acquired Brain Injury
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 6, 2018 |
Est. primary completion date | October 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Miami University | Oxford | Ohio |
Lead Sponsor | Collaborator |
---|---|
Miami University | Duquesne University, University of Arizona, University of Nebraska Lincoln |
United States,
Wagner R. K., Torgesen J. K., Rashotte C. A., Pearson N. A. (2010). Test of Silent Reading Efficiency and Comprehension (TOSREC) examiner's manual. Austin, TX: Pro-Ed.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comprehension Across Conditions (Study 1 of 2) | 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 . | Comprehension accuracy across conditions will be assessed over 1 to 2 days. | |
Primary | Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2) | Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks | 2 weeks | |
Secondary | Comprehension Generalization | Participants will listen to two stories presented in synthetic, computer generated speech and answer comprehension questions about the content of the stories to determine auditory comprehension accuracy | measured 1 week and 4 weeks post termination of treatment | |
Secondary | Perceived Comprehension Accuracy | Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale. | measured 1 week and 4 weeks post termination of treatment |
Status | Clinical Trial | Phase | |
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