UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062664 |
|---|---|
| Receipt number | R000071573 |
| Scientific Title | Effects of Using a Clear-Speech Synthesizer on Communication Effectiveness and Satisfaction in Individuals with Dysarthria in a Day-Care Rehabilitation Setting: An Exploratory A-B-A Design Study |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/24 11:21:19 |
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Basic information
Public title
Effects of Using a Clear-Speech Synthesizer on Communication in People with Dysarthria
Acronym
Clear-Speech Communication Study
Scientific Title
Effects of Using a Clear-Speech Synthesizer on Communication Effectiveness and Satisfaction in Individuals with Dysarthria in a Day-Care Rehabilitation Setting: An Exploratory A-B-A Design Study
Scientific Title:Acronym
Clear-Speech Synthesizer ABA Study
Region
| Japan |
Condition
Condition
Dysarthria
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Communication understandability of participants with dysarthria, as rated by their treating therapists using a questionnaire. Assessments will be conducted at each day-care rehabilitation visit during the baseline phase (A: 2 weeks), clear-speech synthesizer intervention phase (B: 4 weeks), and post-intervention observation phase (A': 2 weeks), and changes across the three phases will be compared.
Key secondary outcomes
1. Satisfaction with communication, as rated by participants using a questionnaire. Assessments will be conducted at each day-care rehabilitation visit during phase A (2 weeks), phase B (4 weeks), and phase A' (2 weeks), and changes across the three phases will be compared.
2. Communication participation assessed using the Japanese 10-item short form of the Communication Participation Item Bank (CPIB-10). The CPIB-10 will be administered at the end of phases A, B, and A', and changes in scores across the three phases will be compared.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
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
| 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 sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Murakami |
Organization
Japan Healthcare University
Division name
Division of Occupational Therapy, Department of Rehabilitation, Faculty of Health Sciences
Zip code
062-0053
Address
1-50, Tsukisamu-higashi 3-jo 11-chome, Toyohira-ku, Sapporo, Hokkaido 062-0053, Japan
TEL
011-351-6100
mskz-murakami@jhu.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Murakami |
Organization
Japan Healthcare University
Division name
Division of Occupational Therapy, Department of Rehabilitation, Faculty of Health Sciences
Zip code
0620053
Address
1-50, Tsukisamu-higashi 3-jo 11-chome, Toyohira-ku, Sapporo, Hokkaido 062-0053, Japan
TEL
0113516100
Homepage URL
mskz-murakami@jhu.ac.jp
Sponsor or person
Institute
Japan Healthcare University
Institute
Department
Personal name
Masakazu Murakami
Funding Source
Organization
National Research and Development Agency New Energy and Industrial Technology Development Organization (NEDO)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Techno System Corporation, Social Medical Corporation Jinseikai Nishibori Hospital, NPO iCare Hokkaido
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Healthcare University Research Ethics Committee
Address
1-50, Tsukisamu-higashi 3-jo 11-chome, Toyohira-ku, Sapporo, Hokkaido 062-0053, Japan
Tel
0113516100
mskz-murakami@jhu.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
通所リハビリテーション西堀（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 24 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071573
