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
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
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
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
