ClinicalTrials.gov
ClinicalTrials.gov Menu

Strategies to Accommodate Reading (STAR) (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03312270
Recruitment Status : Not yet recruiting
First Posted : October 17, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Duquesne University
University of Arizona
University of Nebraska Lincoln
Information provided by (Responsible Party):
Miami University

Brief Summary:

People with aphasia often understand spoken utterances better than written sentences. They also benefit from having content appear in multiple rather than single modalities. Because text-to-speech (TTS) systems accommodate both of these functions, it provides an ideal basis for a reading intervention. TTS systems convert written text to provide both text and auditory information. Research about using TTS supports with people with aphasia has not extended beyond basic case studies and our studies of sentence level comprehension. Hence, no evidence exists about varying TTS features—such as speech output, speech rate, and text highlighting—known to benefit others with reading problems. Also, social acceptance of TTS is not well understood, even though it is critical to adoption and long-term use of the technology.

The purpose of this study is to evaluate various aspects of multimodality presentation of material through TTS systems used by people with aphasia. The immediate outcome of the proposed research will be evidence-based recommendations for selecting and adjusting TTS systems and features. This work will enable clinicians to maximize benefits for adults with varying aphasia profiles. We also will obtain initial evidence about the social validity and perceived value of TTS system use for this population.


Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Multimodality information comprehension Not Applicable

Detailed Description:

Experimental Procedures

  • Phase 1: After completing the assessment session, phase one will include up to 4 sessions each lasting up to 90 minutes. Across the four sessions, the participants will listen to and/or read 36 passages ranging from 4 to 6 sentences each. Then, participants will answer 10 multiple choice questions related to the content of the passage. The researcher will provide comprehension support via written choice strategy for the multiple choice questions (e.g., written and spoken language, nonverbal supports such as pointing). Participants will read and/or listen to the stories via a computer. An example of these questions appears in Appendix G.
  • Phase 2: After completing the assessment session, phase two will include 1 to 3 separate parts examining 3 different TTS features (e.g., speech presentation rate, text highlighting, speech production quality). Participants can choose to participate in 1 or more parts within this phase. For each part, participants will first listen to or view selected variations of a target feature and choose their preferred variation. For each study, participants will then complete five or four experimental sessions lasting up to 90 minutes each. Parts with up to five sessions (i.e., Part 1 and 2) will include features with more variations than those included in Part 3, which will include up to four sessions. Participants will read and/or listen to up to 12 reading passages in each session and answer multiple choice comprehension questions related to the content of the passage. At the conclusion of each session, participants will provide their opinion about the optimal targeted feature variation using rating forms and interview questions. Participants will read and/or listen to the passages via a computer.
  • Phase 3: After completing the assessment session and any previous study phases, the participants will complete one 2-hour session. Participants will complete three activities: (1) education and system exploration guided by a member of the research team, (2) satisfaction and predicted use ratings of TTS systems, and (3) semi-structured interviews. Ratings of the TTS systems will be complete using Likert ratings scales (see Appendix H). Semi-structured interview questions will relate to rationales for system ratings and perceived application of TTS systems for functional use.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Examination of comprehension differences when information is presented under different conditions: (a) written only, (b) auditory only or (c) combined written and auditory.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Strategies to Accommodate Reading (STAR): Using Assistive Technology to Support Reading by People With Aphasia.
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Multimodality information Comprehension
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.
Behavioral: Multimodality information comprehension
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.




Primary Outcome Measures :
  1. 1. What is the accuracy with which people with aphasia comprehend paragraph-level information presented as single modalities (auditory or written) versus multiple modalities (written and auditory)? [ Time Frame: 4 sessions, 9 minutes each over the course of 1 month ]
    Participants will answer questions after listening and/or reading stories


Secondary Outcome Measures :
  1. Which text-to-speech systems feature variations do people with aphasia prefer and derive the most benefit in terms of comprehension accuracy? [ Time Frame: Up to 5 sessions, 90 minutes each over the course of 1 month ]
    Read stories, answer multiple choice questions. Identify feature preferences.

  2. 3. How do people with aphasia perceive and behave when using currently available text-to-speech systems? [ Time Frame: 1 session lasting up to 2 hours ]
    Participants will learn about text-to-speech systems and complete interview about preferences



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of aphasia with reading comprehension impairment resulting from stroke
  • Age 19-90 years
  • At least 6 months post stroke
  • American English is primary language

Exclusion Criteria:

  • Presence of hearing impairment (i.e., prescribed bilateral hearing aids or failed hearing screening)
  • Presence of vision or motor impairments as determined by screening task described below.
  • History of neurological or developmental (reading or learning) impairment other than stroke as determined by self- or family-report.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312270


Contacts
Contact: Kelly Knollman-Porter, PhD 513-529-2504 knollmkk@miamioh.edu
Contact: Saraj Wallace, PhD 412-39604129 wallaces@duq.edu

Sponsors and Collaborators
Miami University
Duquesne University
University of Arizona
University of Nebraska Lincoln
Investigators
Principal Investigator: Kelly Knollman-Porter, PhD Miami University

Responsible Party: Miami University
ClinicalTrials.gov Identifier: NCT03312270     History of Changes
Other Study ID Numbers: 01446r
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing the data because of possible breach of privacy given the small number of local people with aphasia.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miami University:
aphasia
comprehension
text-to-speech
social validity

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms