UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061007 |
|---|---|
| Receipt number | R000069799 |
| Scientific Title | Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/20 22:16:48 |
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Basic information
Public title
Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students
Acronym
Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students
Scientific Title
Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students
Scientific Title:Acronym
Effectiveness of the Rhythm Effect for People Who Stutter: Validation Through Intervention for Japanese-Speaking Elementary School Students
Region
| Japan |
Condition
Condition
developmental stuttering
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of stuttering assessments at each of the following time points: six weeks prior to the intervention; one, three, and six months post-initiation; and six months post-completion.
Key secondary outcomes
Results of the CAT-J at each of the following time points: six weeks pre-intervention; one, three, and six months post-initiation; and six months post-completion.
Results of the OASES-S-J at each of the following time points: six weeks pre-intervention; one, three, and six months post-initiation; and six months post-completion.
Speech in daily life situations (speech during a story retelling task evaluated based on stuttering assessment criteria) at each of the following time points: six weeks pre-intervention; one, three, and six months post-initiation; and six months post-completion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rhythm-based treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 12 | 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 sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanazawa University
Division name
Research Center for Child Mental Development, Institute of Human and Social Sciences
Zip code
920-1192
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-264-5513
kobah@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka University
Division name
United Graduate School of Child Development, Kanazawa Campus
Zip code
920-8640
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-264-5513
Homepage URL
u224642i@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
Tel
076-264-5513
u224642i@ecs.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
みわた小児科（名古屋市）
はる訪問看護リハビリステーション（名古屋市）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069799
