Strategies to Accommodate Reading (STAR)

Aphasia Clinical Trial

— STAR  

Official title:

Strategies to Accommodate Reading (STAR): Using Assistive Technology to Support Reading by People With Aphasia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312270
• Other study ID #: 01446r
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Miami University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Multimodality information comprehension
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.

Locations

Country	Name	City	State
United States	Miami University	Oxford	Ohio
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Miami University	Duquesne University, Quality Living, Inc., University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 sessions, 9 minutes each over the course of 1 month
Secondary	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.	Up to 5 sessions, 90 minutes each over the course of 1 month
Secondary	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	1 session lasting up to 2 hours