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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06323629
Other study ID # STUDY006201
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date March 2025

Study information

Verified date March 2024
Source University of South Florida
Contact Gerald C. Imaezue, PhD
Phone (813)974-2464
Email gimaezue@usf.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is: • To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production? Participants will be engaged in the following activities: - They will perform language and cognitive tasks. - Afterwards, they will receive treatments using tablets and headphones at no cost to them. - The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt. - The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity. - Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 6 months post left hemisphere stroke - Aphasia due to left hemisphere stroke - Dominant English speaker Exclusion Criteria: - Speech-language deficits due to neurological insults such as Parkinson's disease, neurodegenerative conditions etc. - Uncorrected sensory impairments. - Language comprehension impairment. - Severe cognitive impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adaptive recursive self-feedback procedure
The intervention uses self-feedback alone to improve speech production. It adapts the complexity of the treatment tasks.
Non-adaptive recursive self-feedback procedure
The intervention uses self-feedback alone to improve speech production. However, it does not adapt the complexity of the treatment tasks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida Center for Smart Use of Technologies to Assess Real-world Outcomes

Outcome

Type Measure Description Time frame Safety issue
Primary Speaking rate Correct words produced per minute Within 1 week before treatment and within 1 week after treatment.
Primary Speech initiation latency in milliseconds Latency before retrieving the first correct word in an utterance. Within 1 week before treatment and within 1 week after treatment.
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