Narrative Comprehension by People With Acquired Brain Injury

NCT03309930 | Unknown

• 1 other identifier: #01377r
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Traumatic Brain Injury

Keywords

comprehension; Strategies; repeated exposure

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Comprehension Generalization

  measured 1 week and 4 weeks post termination of treatment

• Perceived Comprehension Accuracy

  measured 1 week and 4 weeks post termination of treatment

Study Arms (1)

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.

Behavioral: Comprehension Acquired Brain Injury

Interventions

Comprehension Acquired Brain Injury BEHAVIORAL

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.

Comprehension Acquired Brain Injury

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Miami University: lead
• Duquesne University: collaborator
• University of Nebraska Lincoln: collaborator
• University of Arizona: collaborator

Study Sites (1)

Miami University

Oxford, Ohio, 45056, United States

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Aphasia; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kelly K Knollman-Porter, PhD

  Miami University

  PRINCIPAL INVESTIGATOR

• Sarah Wallace, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly K Knollman-Porter, PhD

CONTACT

7652653640; knollmkk@miamioh.edu

Sarah Wallace, PhD

CONTACT

4123964219; wallaces@duq.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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. .

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 16, 2017
• Study Start: October 6, 2017
• Primary Completion: October 6, 2018
• Study Completion: October 6, 2018
• Last Updated: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)