NCT03312270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

4.1 years

First QC Date

October 12, 2017

Last Update Submit

October 5, 2022

Conditions

Keywords

aphasiacomprehensiontext-to-speechsocial validity

Outcome Measures

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

    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?

    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?

    1 session lasting up to 2 hours

Study Arms (1)

Multimodality information Comprehension

EXPERIMENTAL

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

Behavioral: Multimodality information comprehension

Interventions

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

Multimodality information Comprehension

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami University

Oxford, Ohio, 45056, United States

Location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly Knollman-Porter, PhD

    Miami University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Examination of comprehension differences when information is presented under different conditions: (a) written only, (b) auditory only or (c) combined written and auditory.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

May 1, 2018

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

We will not be sharing the data because of possible breach of privacy given the small number of local people with aphasia.

Locations