Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062664) titled 'Effects of Using a Clear-Speech Synthesizer on Communication in People with Dysarthria' on Aug. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Japan Healthcare University

Condition: Condition - Dysarthria Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this exploratory study is to investigate the effects of using a clear-speech synthesizer equipped with speech recognition technology on communication effectiveness and satisfaction in individuals with dysarthria attending day-care rehabilitation, using an A-B-A design. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - All participants will undergo three consecutive phases in the following order: phase A (baseline), phase B (device intervention), and phase A' (post-intervention observation).

Phase A (2 weeks): Participants will attend usual day-care rehabilitation without using the clear-speech synthesizer.

Phase B (4 weeks): Participants will use the clear-speech synthesizer during communication in the day-care rehabilitation setting. The participant's speech will be input into the device, converted into more intelligible synthesized speech, and the converted speech will be used for communication.

Phase A' (2 weeks): Use of the clear-speech synthesizer will be discontinued, and participants will again attend usual day-care rehabilitation without using the device.

Participants are expected to attend day-care rehabilitation approximately twice per week. The total study period for each participant will be 8 weeks.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants who meet all of the following criteria will be eligible:

1. Aged 18 years or older 2. Receiving day-care rehabilitation services at Day-Care Rehabilitation Nishibori 3. Having dysarthria 4. Able to understand the explanation of the study 5. Able to provide written informed consent to participate in the study 6. Considered able to participate in the study by their treating therapist Key exclusion criteria - Participants who meet any of the following criteria will be excluded:

1. Severe cognitive impairment that makes it difficult to complete the study procedures 2. Severe hearing impairment or other conditions that make participation in the study difficult 3. Considered unsuitable for participation by the principal investigator Target Size - 3

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 08 Month 17 Day Date of IRB - 2026 Year 08 Month 17 Day Anticipated trial start date - 2026 Year 08 Month 17 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071573

Disclaimer: Curated by HT Syndication.