UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049922 |
|---|---|
| Receipt number | R000056857 |
| Scientific Title | Determination of rehabilitation effects on sensory and motor functions related to feeding and swallowing |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/27 20:02:53 |
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Basic information
Public title
Determination of rehabilitation effects on sensory and motor functions related to feeding and swallowing
Acronym
Determination of rehabilitation effects on sensory and motor functions related to feeding and swallowing
Scientific Title
Determination of rehabilitation effects on sensory and motor functions related to feeding and swallowing
Scientific Title:Acronym
Determination of rehabilitation effects on sensory and motor functions related to feeding and swallowing
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of current dysphagia rehabilitation techniques on oral function during oral phase of feeding and swallowing in healthy and oral hypofunction subjects.
Basic objectives2
Others
Basic objectives -Others
Evaluate the effect of dysphagia rehabilitation on various oral functions before and after intervention.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of pharyngeal transit velocity of food by ultrasound device. (after 4 and 8 weeks of intervention)
Key secondary outcomes
Electromyographic recording of masseter muscle and suprahyoid muscle group by surface electromyography, EAT-10, Repeated salivary swallow test, Tongue pressure, Roughness sensation sensitivity. (after 4 and 8 weeks of 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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Jaw Opening Exercise group.
The exercise is performed in a sitting position with a stable torso. The subject is asked to open the mouth to the maximum extent possible, and to hold it for 10 seconds while being conscious of the strong contraction of the suprahyoid muscles, and then rest for 10 seconds, repeating the exercise 5 times. With this as 1 set, subjects perform this training 3 times a week for 3 sets a day.
Interventions/Control_2
Lingual Resistance Exercise group.
Using tongue pressure measuring device (JMS tongue pressure measuring device / GC Co., Ltd.). The subject performs a repetitive action of pressing the tongue apex against the hard palate at 100% of maximum tongue pressure, holding for 10 seconds, and resting for 10 seconds, repeating the exercise 5 times. With this as 1 set, subjects perform this training 3 times a week for 3 sets a day.
Interventions/Control_3
Tongue-Hold Swallow Exercise group.
The subject performs an empty swallow by holding the tongue lightly between the upper and lower incisors while the tongue is parroted forward, repeating the exercise 5 times. With this as 1 set, subjects perform this training 3 times a week for 3 sets a day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy or oral hypofunction volunteer subjects will be recruited if they meet the following inclusion criteria. The distinction between healthy and oral hypofunction subjects are based solely on the diagnostic criteria for oral hypofunction proposed by the Japanese Society of Gerodontology, with no specific conditions such as oral prosthetic condition.
(1) Adults 20 years of age or older.
(2) Those who have given written consent to participate in this study.
Key exclusion criteria
Those who meets any of the following criteria.
(1) With pain or known sensory disturbance in the craniofacial region.
(2) Those who have a disease that may cause neurological impairment.
(3) Those who are scheduled to undergo deficient prosthodontic treatment during the 8-week intervention period.
(4) With allergies to equipment or foods used in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Aging and Geriatric Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-8396
yoshihiko.ito.b7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Aging and Geriatric Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-8396
Homepage URL
yoshihiko.ito.b7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Yoshihiko Ito
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Division of Aging and Geriatric Dentistry, Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022-717-8396
yoshihiko.ito.b7@tohoku.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 28 | 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
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056857
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