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CompletedNCT03312270STARUpdated Oct 6, 2022

Strategies to Accommodate Reading (STAR)

An interventional study of Multimodality information comprehension in Aphasia, sponsored by Miami University. Completed at 2 sites in United States. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Miami University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Not applicable
Ages
19 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 175 studies in Aphasia with a site in United States — 50 open to participants now, 60 under way, 1 of them phase 3. Aphasia · United States.

Enrollment
8th of 158
152 · median 30
Started
2018
with 14 others
No phase
130 of 175
36 open now
Registered
67th of 175
by date

Among the 175 studies in Aphasia with a site in United States, this one is the 8th largest by enrollment of the 158 interventional ones that give a count, is one of 15 that started in 2018, is one of 130 with no phase, and was the 67th registered.

Aphasia

338 studies on the registry are indexed under Aphasia; 94 are open to participants now.

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Open to participants now

50 of the 175 studies in Aphasia with a site in United States are open now. Recruiting first, the newest first:

45 more — sign in →

All 50 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 67 Aphasia studies recruiting now, 30 (45%) set no upper age limit and 11 (16%) stop at 75 or younger; 1 takes children under 18; 16 take healthy volunteers.

This study: 19 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.
03

Conditions studied

  • Aphasia

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Keywords

  • aphasia
  • comprehension
  • text-to-speech
  • social validity
04

Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
152 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralMultimodality information comprehension

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

06

What researchers measure

Primary outcomes

  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)?

    Participants will answer questions after listening and/or reading stories

    Time frame: 4 sessions, 9 minutes each over the course of 1 month

Secondary outcomes

  1. 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.

    Time frame: Up to 5 sessions, 90 minutes each over the course of 1 month

  2. 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

    Time frame: 1 session lasting up to 2 hours

07

Study locations

2 sites
  • Miami University
    Oxford, Ohio 45056, United States
  • Duquesne University
    Pittsburgh, Pennsylvania 15282, United States
08

References and documents

Individual participant data

Plan to share: No — We will not be sharing the data because of possible breach of privacy given the small number of local people with aphasia.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Jun 2022, 49 months.

Of 183 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's 49 months is above that.

Counting every sponsor, half of 185 studies reached it within 36 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 17, 2017
StartActual
May 1, 2018
Primary completionActual
Jun 1, 2022
CompletionActual
Jun 1, 2022
Last update
Oct 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312270
Lead sponsor
Miami University
Collaborators
Duquesne University, University of Arizona, Quality Living, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
May 1, 2018
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Oct 6, 2022

Study contacts

Kelly Knollman-Porter, PhD
principal investigator · Miami University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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