UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058590 |
|---|---|
| Receipt number | R000066788 |
| Scientific Title | Effectiveness of Tongue Pressure Training with Biofeedback in Patients with Sarcopenic Dysphagia |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/24 18:47:16 |
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Basic information
Public title
Effectiveness of Tongue Pressure Training with Biofeedback in Patients with Sarcopenic Dysphagia
Acronym
Biofeedback-Based Tongue Pressure Training in Patients with Sarcopenic Dysphagia
Scientific Title
Effectiveness of Tongue Pressure Training with Biofeedback in Patients with Sarcopenic Dysphagia
Scientific Title:Acronym
Biofeedback-Based Tongue Pressure Training in Patients with Sarcopenic Dysphagia
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of tongue pressure training using biofeedback on improving tongue pressure and oral intake level in patients with sarcopenic dysphagia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal tongue pressure (1:post-intervention /2:discharge)
Key secondary outcomes
Functional oral intake scale score (post-intervention / discharge)
Improvement in dietary texture (staple food, side dish, or liquids) (post-intervention / discharge)
Number of self-training sessions for tongue pressure (during the intervention period)
Motivation for dysphagia rehabilitation (during the intervention period)
Self-perceived evaluation of swallowing function (post-intervention)
Videofluoroscopic Dysphagia Scale (post-intervention)
Penetration-Aspiration Scale (post-intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Biofeedback during tongue pressure training
During a session, real-time feedback on tongue pressure is displayed on a computer screen.
Three types of exercises are included:
Maximal strength training, performed at >=80% of the participant's maximum tongue pressure.
Accuracy training, performed at target levels of 70% of the maximum tongue pressure.
Accuracy training, performed at target levels of 50% of the maximum tongue pressure.
Isotonic tongue pressure exercises: three sets of ten repetitions for each exercise.
Interventions/Control_2
No biofeedback during tongue pressure training
Three types of exercises are included:
Maximal strength training, performed by exerting maximal tongue pressure.
Accuracy training, performed based on the perceived effort corresponding to 70% of maximal tongue pressure.
Accuracy training, performed based on the perceived effort corresponding to 50% of maximal tongue pressure.
Isotonic tongue pressure exercises: three sets of ten repetitions for each exercise.
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Admitted to a convalescent rehabilitation ward.
Received a prescription for dysphagia rehabilitation by a speech-language therapist.
Presence of sarcopenia, diagnosed according to the Asian Working Group for Sarcopenia (AWGS) 2019 criteria.
A score of 5 or lower on the Functional Oral Intake Scale (FOIS).
A Mini-Mental State Examination (MMSE) score of >=15.
Key exclusion criteria
Presence of dysphagia caused by cerebrovascular disease, neuromuscular disease, or structural abnormalities.
Medically unstable condition that makes it impossible to follow the training protocol.
Expected length of stay in a convalescent rehabilitation ward of less than six weeks.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Kotomi |
| Middle name | |
| Last name | Sakai |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Department of Research
Zip code
151-0053
Address
2F A Building, Kita-Sando, 1-3-1 Yoyogi, Shibuya-ku, Tokyo
TEL
0367126401
sakai.kotomi@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Kotomi |
| Middle name | |
| Last name | Sakai |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Department of Research
Zip code
151-0053
Address
2F A Building, Kita-Sando, 1-3-1 Yoyogi, Shibuya-ku, Tokyo
TEL
03-6712-6401
Homepage URL
sakai.kotomi@hmw.gr.jp
Sponsor or person
Institute
Heisei Medical Welfare Group Research Institute
Institute
Department
Personal name
Funding Source
Organization
None
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
Heisei Medical Welfare Group Research Institute
Address
2F A Building, Kita-Sando, 1-3-1 Yoyogi, Shibuya-ku, Tokyo
Tel
03-6712-6401
info.research@hmw.gr.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
淀川平成病院、堺平成病院、岸和田平成病院、平成横浜病院、緑成会病院、博愛記念病院、江藤病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066788
