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Narrative Comprehension by People With Acquired Brain Injury

Primary Purpose

Aphasia, Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehension Acquired Brain Injury
Sponsored by
Miami University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aphasia focused on measuring comprehension, Strategies, repeated exposure

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Miami UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comprehension Acquired Brain Injury

Arm Description

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.

Outcomes

Primary Outcome Measures

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 .
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

Secondary Outcome Measures

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
Perceived Comprehension Accuracy
Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale.

Full Information

First Posted
October 9, 2017
Last Updated
October 12, 2017
Sponsor
Miami University
Collaborators
Duquesne University, University of Nebraska Lincoln, University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03309930
Brief Title
Narrative Comprehension by People With Acquired Brain Injury
Official Title
Narrative Comprehension by People With Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
October 6, 2018 (Anticipated)
Study Completion Date
October 6, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miami University
Collaborators
Duquesne University, University of Nebraska Lincoln, University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. Post-Testing Sessions One Post-Testing Session will occur within 1 week after the last practice session ends. It will last about 60 minutes. Post-Testing tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the 45 Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QRI stories from one condition (Synthetic 1). o Following completion of the procedure above, participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5-point Likert scale. These questions appear in Appendix G. The Maintenance Session will occur about 4 weeks after the last practice session ends. It will last approximately 60 minutes. The Maintenance Session tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QI stories from one condition (Synthetic 1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Traumatic Brain Injury
Keywords
comprehension, Strategies, repeated exposure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
During Study 1 participants will be exposed to three different conditions: (a) written text only, (b) auditory synthetic speech output only and (c) a combined condition (written and auditory output). During Study 2 participants will be provided repeated exposure to synthetic speech. Participants can participate in 1 or both studies with 1 study results not being dependent on the other study. .
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comprehension Acquired Brain Injury
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comprehension Acquired Brain Injury
Intervention Description
For study 1 participants will be exposed to 3 conditions as stated in previous descriptions and will last 1 to 2 sessions. Study 2 will begin with 1 session with the researcher lasting about 30 minutes. Then participants will be asked to complete practice at home for about 15 minutes each day for 2 weeks using a computer/iPad. Study 2 Post Testing and Maintenance Sessions 1 and 2: approximately 60 minutes per session.
Primary Outcome Measure Information:
Title
Comprehension Across Conditions (Study 1 of 2)
Description
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 .
Time Frame
Comprehension accuracy across conditions will be assessed over 1 to 2 days.
Title
Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2)
Description
Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Comprehension Generalization
Description
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
Time Frame
measured 1 week and 4 weeks post termination of treatment
Title
Perceived Comprehension Accuracy
Description
Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale.
Time Frame
measured 1 week and 4 weeks post termination of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly K Knollman-Porter, PhD
Phone
7652653640
Email
knollmkk@miamioh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Wallace, PhD
Phone
4123964219
Email
wallaces@duq.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Knollman-Porter, PhD
Organizational Affiliation
Miami University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Wallace, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami University
City
Oxford
State/Province
Ohio
ZIP/Postal Code
45056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly K Knollman-Porter, PhD
Phone
765-265-3640
Email
knollmkk@miamioh.edu
First Name & Middle Initial & Last Name & Degree
Susan Brehm, PhD
Phone
513-529-2553
Email
bakerse1@miamioh.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing the data because of possible breach of privacy given the small number of local people with acquired brain injury/stroke.
Citations:
Citation
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.
Results Reference
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Narrative Comprehension by People With Acquired Brain Injury

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