Speech Hero Home Therapy for Aphasia

Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia

The investigators will run an at-home usability study of a newly developed speech therapy app called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke. The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week period.

Study Overview

• Status: Completed
• Conditions: Broca Aphasia
• Intervention / Treatment: Device: At home Speech Hero therapy app

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75080
      • Callier Center at University of Texas Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Broca's aphasia due to stroke,
• >6 months post stroke
• sufficient motor function of the unaffected upper extremity to tap on a table while speaking

Exclusion Criteria:

• Incidence of other neurological diseases (though individuals with apraxia will be included)
• age <85

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: At home Speech Hero therapy	Device: At home Speech Hero therapy app; Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks	Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues.	Immediately Post-Treatment, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on Western Aphasia Battery	Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment).	Immediately Post-Treatment, an average of 4 weeks
Change in Score on Boston Naming Test	Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment).	Immediately Post-Treatment, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Flint Rehabilitation Devices, LLC
• Collaborators: University of Texas
• Investigators: Principal Investigator: Yune Lee, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2021
• Primary Completion (ACTUAL): October 15, 2021
• Study Completion (ACTUAL): October 20, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia; Aphasia, Broca
• Other Study ID Numbers: 1R43DC018771-01 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No