AphasiaSTARNCT03312270
Strategies to Accommodate Reading (STAR)
A study testing Multimodality information comprehension in people with Aphasia, run by Miami University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Multimodality information comprehension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2018to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miami University
Oxford, Ohio, 45056
Duquesne University
Pittsburgh, Pennsylvania, 15282
About this study
Official title: Strategies to Accommodate Reading (STAR): Using Assistive Technology to Support Reading by People With Aphasia.
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.
- Conditions
- Aphasia
- Being tested
- Multimodality information comprehension
- Keywords
- aphasia, comprehension, text-to-speech, social validity
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodality information comprehensionBehavioural
Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.
| Study group | Role | What they receive |
|---|---|---|
| Multimodality information Comprehension | Experimental | Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia. Receives: Behavioral: Multimodality information comprehension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 sessions, 9 minutes each over the course of 1 month
Secondary outcomes (2)
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.
Measured: Up to 5 sessions, 90 minutes each over the course of 1 month
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
Measured: 1 session lasting up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 May 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- Duquesne University, University of Arizona, Quality Living, Inc.
- Responsible party
- Sponsor
- Investigators
- Kelly Knollman-Porter, PhD, Principal investigator, Miami University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312270
- Sponsor's protocol ID
- 01446r
- Acronym
- STAR
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2017
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing the data because of possible breach of privacy given the small number of local people with aphasia.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Accommodate Reading (STAR): Using Assistive Technology to Support Reading by People With Aphasia.
- ClinicalTrials.gov ID
- NCT03312270
- Acronym / sponsor ID
- STAR / 01446r
- Conditions
- Aphasia
- Keywords
- aphasia, comprehension, text-to-speech, social validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- Duquesne University, University of Arizona, Quality Living, Inc.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multimodality information Comprehension | Experimental | Behavioral: Multimodality information comprehensionEvaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodality information comprehensionEvaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia. | Behavioural | Multimodality information Comprehension |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No. We will not be sharing the data because of possible breach of privacy given the small number of local people with aphasia.
Related trials for Aphasia
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Knollman-Porter, PhD principal investigator
Miami University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodality information comprehension in people with Aphasia, run by Miami University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.