UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014986 |
|---|---|
| Receipt number | R000016935 |
| Scientific Title | Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia. |
| Date of disclosure of the study information | 2014/08/29 |
| Last modified on | 2021/03/04 09:04:15 |
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Basic information
Public title
Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Acronym
ORACLE trial for dementia
Scientific Title
Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Scientific Title:Acronym
ORACLE trial for dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of oral myofunctional training for dementia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MMSE
Key secondary outcomes
Background (gender, age, medical history, medication), response to calling the name, CDR-J, NPI-NH, Vitality Index, Barthel Index, GDS, PHQ9, Flow-mediated vasodiation (FMD), blood pressure, pulses, grip test, holter electrocardiography, adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions) Oral myofunctional training (3 min, 5 times per day) program for 6 month
Interventions/Control_2
Control) Standard care and visiting 3 min, 5 times per day for 3 month, then start oral myofunctinlal training (3 min 5 times per day ) program for 3 month
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Dementia person
2) Person whose MMSE score less than 24
Key exclusion criteria
1) Person who is mechanically ventilated
2) Person who has serious conditions in the oral cavity
3) In case the doctor finds any difficulty for participation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Graduate of Medical Sciences, Department of Cardiovascular Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-641-1151
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Graduate School of Medical Sciences
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-641-1151
Homepage URL
tomomi_i@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research network Fukuoka
Address
3-1-1, maidashi, Higashiku, Fukuoka
Tel
0926437171
mail@crnfukuoka.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
・医療法人白十字会 介護老人保健施設 サン 施設長 石橋経久
〒857-1165 佐世保市大和町30番地 TEL 0956-33-7771
社会福祉法人 椿ヶ丘 特別養護老人ホーム椿ヶ丘荘 理事長 石司有理子
〒851-2404 長崎県長崎市神浦丸尾町１５５３ TEL 0959-24-0130
社会福祉法人 敬天会 牧島荘 理事長 栗林紘子
〒851-0114 長崎県長崎市牧島町9-1 TEL 095-837-0310
・社会福祉法人 白寿会 白寿荘 施設長 迎 正樹
〒858-0922 長崎県佐世保市鹿子前町904-1 TEL 0956-28-1181
医療法人秋桜会 介護老人保健施設 コスモスガーデン桜の里
総括本部長 入口初則
〒851-2207 長崎県長崎市さくらの里２丁目２７－２８ TEL 095-840-1200
・燿光リハビリテーション病院 院長 大財 茂
〒857-0022 長崎県佐世保市山手町855-1 TEL 0956-25-3210
・社会福祉法人佐世保白寿会 介護保健施設 さざ・煌めきの里 施設長 牧山弘孝
〒857-0337 長崎県来た松浦郡佐々町八口免805-2 TEL 0956-41-1122
・社会医療法人財団 白十字会 介護老人保健施設 長寿苑
施設長 長田 征三、苑長 南 祐三
〒857-1151 長崎県佐世保市日宇町2835 TEL 0956-32-3800
介護老人保健施設カリタス
〒851-2322 長崎県長崎市西出津町67-5 TEL 0959-25-1555
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 29 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016935
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
