UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061802 |
|---|---|
| Receipt number | R000070721 |
| Scientific Title | Efficacy of Masticatory Rehabilitation Using Rice Crackers for Patients with Eating and Swallowing Disorders: An Assessor-Blinded Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/04 19:19:09 |
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Basic information
Public title
Efficacy of Masticatory Rehabilitation Using Rice Confectionery for Patients with Eating and Swallowing Disorders
Acronym
Evaluation of the efficacy of masticatory rehabilitation using rice crackers for patients with dysphagia: a randomized controlled trial
Scientific Title
Efficacy of Masticatory Rehabilitation Using Rice Crackers for Patients with Eating and Swallowing Disorders: An Assessor-Blinded Randomized Controlled Trial
Scientific Title:Acronym
SakuSaku Reha
Region
| Japan |
Condition
Condition
Post-stroke dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether masticatory rehabilitation using rice crackers (SakuSaku Reha) improves masticatory function in post-stroke inpatients consuming texture-modified diets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circular motion frequency of the mandible
Change in the circular motion frequency during mastication from baseline to post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Masticatory rehabilitation using rice crackers (SakuSaku Reha) is implemented.
Interventions/Control_2
Standard dysphagia rehabilitation are implemented.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Post-stroke patients hospitalized at our institution who received dental consultation during their stay.
Patients prescribed with dysphagia rehabilitation (rehabilitation for feeding and swallowing function).
Patients consuming modified diets (e.g., pureed or minced-and-thickened diets) with a Food Intake Level Scale (FILS) score of 7 or 8.
Patients who tested positive on the SakuSaku-test.
Key exclusion criteria
Patients who are unable to understand simple instructions.
Patients without posterior occlusal support (Eichner classification B4 and C; patients with Eichner A1 to B3 are included).
Patients with structural problems or pain during mastication, such as oral cancer or ill-fitting dentures.
Patients who experienced aspiration during the SakuSaku-test.
Patients who do not provide consent to participate in the study.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Nomoto |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Dentistry
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
tatans.123.tatata@gmail.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nomoto |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Dentistry
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
Homepage URL
n.akiko-dent@sis.seirei.or.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu City Rehabilitation Hospital
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel
053-471-8331
kamiya@sis.seirei.or.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 04 | 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
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070721
