Recruiting

Observational Study

Sponsor:

Miami University

Code:

NCT03309930

Conditions

Aphasia

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Comprehension Acquired Brain Injury

Study Details

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

Study ID

NCT03309930

Start date

Oct 6, 2017

Status verified date

Oct, 2017

Completion date

Oct 6, 2018

Anticipated

Primary completion date

Oct 6, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Comprehension Acquired Brain Injury

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.

Interventions

Comprehension Acquired Brain Injury

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

  • Comprehension Across Conditions (Study 1 of 2) [ Time Frame: Comprehension accuracy across conditions will be assessed over 1 to 2 days. ]
  • Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Kelly K Knollman-Porter, PhD

7652653640knollmkk@miamioh.edu

Sarah Wallace, PhD

4123964219wallaces@duq.edu

Locations

Miami University

Recruiting

Oxford, Ohio, United States, 45056

Contacts

Kelly K Knollman-Porter, PhD

765-265-3640knollmkk@miamioh.edu

Susan Brehm, PhD

513-529-2553bakerse1@miamioh.edu

More Information

Sponsor

Miami University

Last update posted

Oct 16, 2017

Last verified

Oct, 2017

Keywords

  • comprehension
  • Strategies
  • repeated exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Miami University on 2017-10-16.