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Strategies to Accommodate Reading (STAR) (STAR)

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimodality information comprehension
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 aphasia, comprehension, text-to-speech, social validity

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Miami University
  • Duquesne University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multimodality information Comprehension

Arm Description

Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.

Outcomes

Primary Outcome Measures

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)?
Participants will answer questions after listening and/or reading stories

Secondary Outcome Measures

Which text-to-speech systems feature variations do people with aphasia prefer and derive the most benefit in terms of comprehension accuracy?
Read stories, answer multiple choice questions. Identify feature preferences.
3. How do people with aphasia perceive and behave when using currently available text-to-speech systems?
Participants will learn about text-to-speech systems and complete interview about preferences

Full Information

First Posted
October 12, 2017
Last Updated
October 5, 2022
Sponsor
Miami University
Collaborators
Duquesne University, University of Arizona, Quality Living, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03312270
Brief Title
Strategies to Accommodate Reading (STAR)
Acronym
STAR
Official Title
Strategies to Accommodate Reading (STAR): Using Assistive Technology to Support Reading by People With Aphasia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miami University
Collaborators
Duquesne University, University of Arizona, Quality Living, Inc.

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
aphasia, comprehension, text-to-speech, social validity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodality information Comprehension
Arm Type
Experimental
Arm Description
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.
Intervention Type
Behavioral
Intervention Name(s)
Multimodality information comprehension
Intervention Description
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.
Primary Outcome Measure Information:
Title
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)?
Description
Participants will answer questions after listening and/or reading stories
Time Frame
4 sessions, 9 minutes each over the course of 1 month
Secondary Outcome Measure Information:
Title
Which text-to-speech systems feature variations do people with aphasia prefer and derive the most benefit in terms of comprehension accuracy?
Description
Read stories, answer multiple choice questions. Identify feature preferences.
Time Frame
Up to 5 sessions, 90 minutes each over the course of 1 month
Title
3. How do people with aphasia perceive and behave when using currently available text-to-speech systems?
Description
Participants will learn about text-to-speech systems and complete interview about preferences
Time Frame
1 session lasting up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Knollman-Porter, PhD
Organizational Affiliation
Miami University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami University
City
Oxford
State/Province
Ohio
ZIP/Postal Code
45056
Country
United States
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States

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 aphasia.

Learn more about this trial

Strategies to Accommodate Reading (STAR)

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