Clinical Study on the Efficacy and Reliability of Speech Intelligibility Assessment for Post-stroke Patients Using an AI Solution
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Word-level consonant accuracy (%) derived from speech samples obtained during the U-TAP assessment
Study Overview
Brief Summary
compare the auditory-perceptual assessment conducted by speech-language pathologists using the U-TAP with the assessment performed via the AI solution (Blings) program in patients with speech disorders, and to evaluate the efficacy and reliability of these two methods for speech intelligibility assessment.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older.
- •Patients with neurologic disorders, including amyotrophic lateral sclerosis, poliomyelitis, cerebellar disorders, cerebellar lesions, and stroke.
- •Patients presenting with concomitant speech disorders, such as dysarthria, motor speech disorders, and voice disorders.
Exclusion Criteria
- •Subjects with a score of less than 16 points on the Korean Mini-Mental State Examination (K-MMSE).
- •Subjects with visual, perceptual, or auditory impairments that prevent them from following the examiner's instructions.
- •Subjects judged by the researcher as unsuitable for participation in this clinical study due to other reasons.
Outcomes
Primary Outcomes
Word-level consonant accuracy (%) derived from speech samples obtained during the U-TAP assessment
Time Frame: Visit 1 (Baseline)
The agreement between consonant accuracy analyzed by the AI-based speech disorder analysis program (Blings) and the evaluations conducted independently by two certified speech-language pathologists (Rater 1 and Rater 2). Consonant accuracy is calculated at the word level and expressed as a percentage score ranging from 0% to 100%. The mean value of consonant accuracy scores from Rater 1 and Rater 2 is used as the reference human evaluation.
Secondary Outcomes
- Test-retest reliability of word-level consonant accuracy (%) calculated by Blings(Visit 1 and Visit 2 (7 ± 5 days interval))
- Inter-rater agreement of word-level consonant accuracy (%) among Blings, Rater 1, and Rater 2(Visit 1 and Visit 2 (7 ± 5 days interval))
- Time required to complete speech analysis (seconds)(Visit 1 and Visit 2 (7 ± 5 days interval))
Investigators
Yong-il Shin
Prof.
Pusan National University Yangsan Hospital