UMIN-CTR Clinical Trial

Basic information
Public title	Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Acronym	Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Scientific Title	Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes: a randomized open trial
Scientific Title:Acronym	Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes
Region	Japan

Condition
Condition	dementia
Classification by specialty	Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of regular tongue training on oral frailty in dementia patients living in nursing homes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Maximum tongue pressure * Assess the measured value at the screening and at four, eight, and 12 weeks after the start of training and calculate the amount of change from at the screening.
Key secondary outcomes	1. Repetitive saliva swallowing test (RSST) 2. Oral diadochokinetic (ODK) rate 3. Oral assessment 4. Geriatric Oral Health Assessment Index (GOHAI) *1-4 Assess the measured value at the screening and at four, eight, and 12 weeks after the start of training and calculate the amount of change from at the screening.

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Duration: 12 weeks Intervention: Oral care program Administration: dental brushing, tongue cleaning, and oral massage
Interventions/Control_2	Duration: 12 weeks Intervention: Oral care program + Tongue training Administration: In addition to oral care program, tongue training with Peko-panda (JMS Co., Ltd.) is performed twice a week, three sets of less than six times/set.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects aged 65 or over who were diagnosed with dementia and were living in nursing homes where Medical Corporation Shinseikai involves in intraoral care 2. Subjects who are judged as eligible to participate in the study by the principal investigator 3. Subjects whose maximum tongue pressure is less than 30 kPa at screening (baseline) 4. If number of people whose maximum tongue pressure is less than 30 kPa at screening (baseline) exceed the sample size, select subjects with relatively low value in maximum tongue pressure
Key exclusion criteria	1. Subjects who are ineligibility to participate in the study based on the evaluation of the principal investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name HAMAJIMA
Organization	Medical Corporation Shinseikai
Division name	director
Zip code	331-0071
Address	266 Takagi, Nishi-ku, Saitama-shi, Saitama, Japan
TEL	048-625-7581
Email	takuya-hamajima@shinsei-gr.com

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Kouyu Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Takara Clinic Certified Review Board
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	CRB@takara-clinic.com

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs032190193
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団新聖会 (埼玉県) が口腔ケアを担当するグループホーム The nursing homes where Medical Corporation Shinseikai (Saitama, Japan) involves in intraoral care

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 06 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	Enrolling by invitation
Date of protocol fixation	2019 Year 11 Month 19 Day
Date of IRB	2019 Year 12 Month 03 Day
Anticipated trial start date	2020 Year 02 Month 29 Day
Last follow-up date	2021 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	2020 Year 02 Month 06 Day
Last modified on	2020 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044930