UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039407
Receipt number R000044930
Scientific Title Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes: a randomized open trial
Date of disclosure of the study information 2020/02/06
Last modified on 2020/08/07 10:45:45

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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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name