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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033518
Receipt No. R000037412
Official scientific title of the study Effects of tongue elevation training with hanging scale for healthy individuals
Date of disclosure of the study information 2018/08/02
Last modified on 2018/07/26

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Basic information
Official scientific title of the study Effects of tongue elevation training with hanging scale for healthy individuals
Title of the study (Brief title) 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 Kazuhisa Domen
Organization Hyogo collage of medicine
Division name Department of rehabilitation
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6644
Email office@craseed.org

Public contact
Name of contact person Kohei Horikawa
Organization Hospital of Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6345
Homepage URL
Email ko-horikawa@hyo-med.ac.jp

Sponsor
Institute Hospital of Hyogo College of Medicine
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 08 Month 02 Day
Anticipated trial start date
2018 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 26 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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