UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033518 |
|---|---|
| Receipt number | R000037412 |
| Scientific Title | Effects of tongue elevation training with hanging scale for healthy individuals |
| Date of disclosure of the study information | 2018/08/02 |
| Last modified on | 2020/12/05 19:19:58 |
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Basic information
Public title
Effects of tongue elevation training with hanging scale for healthy individuals
Acronym
Effects of tongue elevation training with hanging scale for healthy individuals
Scientific Title
Effects of tongue elevation training with hanging scale for healthy individuals
Scientific Title:Acronym
Effects of tongue elevation training with hanging scale for healthy individuals
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of tongue elevation training with hanging scale on oral function and swallowing function for healthy individuals
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum Traction force
Key secondary outcomes
1.Maximum tongue pressure value measured by JMS tongue pressure device
2.The tongue pressure value during the water effort swallowing measured by Swallowscan
3.Acoustic analysis of Oral Diadochokinesis
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
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The gauze is fixed on the hanging scale. Participants are instructed to keep the gauze inserted in the oral cavity in contact with the tongue and palate. The gaze is directed horizontally, and the gauze is driven downward from the horizontal plane by 30 degrees. The training strength is 80% of the maximum traction force, and traing is performed for five seconds, 10 times per set, one set per day, three days a week, and seven weeks.
Interventions/Control_2
No training
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In the past, there are no subjective or objective problems concerning oral motor function, speech and swallowing.
Key exclusion criteria
Participants are excluded with following criteria.
Organic defect in the palate, tongue and mandibular. History of diseases that may affect oral motor function, speech, and swallowing, such as strokes. Difficulties of following the traing instructions by advanced dementia, higher brain dysfunction and aphasia. Gingival retraction with periodontal disease in the upper and lower incisor teeth, lateral incisor, and canines. Mucosal flame in the palate or tongue.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo collage of medicine
Division name
Department of rehabilitation
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6644
office@craseed.org
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Horikawa |
Organization
Hospital of Hyogo College of Medicine
Division name
Department of physical medicine and rehabilitation
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6345
Homepage URL
ko-horikawa@hyo-med.ac.jp
Sponsor or person
Institute
Hospital of Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Speech-Language-Hearing Therapists
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
Center for Clinical Research and Education
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6006
chiken02@hyo-med.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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
https://webview.isho.jp/journal/toc/13495828/17/3
Publication of results
Published
Result
URL related to results and publications
https://webview.isho.jp/journal/toc/13495828/17/3
Number of participants that the trial has enrolled
27
Results
Twenty-seven of the 30 subjects completed the training, and there were no adverse events due to this training. No significant difference was observed between the two groups in terms of attributes and all endpoints. No significant difference was observed in all the endpoints in the control group. On the other hand, in the intervention group, significant increases were observed in maximum retention, maximum tongue pressure, Ch.1,2,4,5 tongue pressure.
Results date posted
| 2020 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 healthy young people (24 males and 6 females) under the age of 40 who did not find any subjective abnormalities in oral movement, articulation, or swallowing and consented to participate in the study. , Average age 26.4 years).
Participant flow
The study design adopted a quasi-randomized controlled trial. The group that received tongue-palatal contact training was the intervention group, and the group that did not receive it was the control group, and they were assigned to two groups by the envelope method. Stratification randomization was performed to evenly distribute the number of men and women in each group. After allocation, both groups underwent initial evaluation, the intervention group underwent final evaluation after training, and the control group underwent final evaluation 8 weeks after initial evaluation without training.
Adverse events
None
Outcome measures
1) Maximal holding power
2) Maximal tongue pressure
3) Tongue pressure during swallowing
4) The number of oral diadochokinesis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037412
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| Registered date | File name |
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