Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061007) titled 'Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kanazawa University
Condition:
Condition - developmental stuttering
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study verifies the effectiveness of an intervention based on the "rhythm effect," which reduces stuttering by repeating rhythmic speech, in the Japanese language.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Rhythm-based treatment
Eligibility:
Age-lower limit - 6
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Diagnosed with developmental stuttering by a physician based on either the ICD-10 or DSM-5 criteria.
2. Enrolled in elementary school at the start of the intervention.
3. Still attending elementary school at the end of the intervention.
Key exclusion criteria - 1. Prior experience with an intervention using rhythm effects.
2. Received professional intervention for stuttering within the past six months.
3. Limited proficiency in Japanese, for example, due to being raised by a caregiver with a non-Japanese linguistic background.
Target Size - 35
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 02 Month 13 Day
Date of IRB - 2026 Year 02 Month 13 Day
Anticipated trial start date - 2026 Year 02 Month 13 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069799
Disclaimer: Curated by HT Syndication.
