Unique ID issued by UMIN | UMIN000011488 |
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Receipt number | R000013407 |
Scientific Title | Pilot Study for ORAl myofunctional CLinical Evidence: dementia |
Date of disclosure of the study information | 2013/08/14 |
Last modified on | 2020/03/11 17:35:22 |
Pilot Study for ORAl myofunctional CLinical Evidence: dementia
ORACLE Pilot, TSUBAKI-2
Pilot Study for ORAl myofunctional CLinical Evidence: dementia
ORACLE Pilot, TSUBAKI-2
Japan |
Dementia persons
Geriatrics | Psychiatry |
Others
NO
To perform pilot study for creating evidence of oral myofunctional training for dementia persons in cognitive and physical conditions and care burden.
Efficacy
Exploratory
Pragmatic
Not applicable
Degree of care burden (NIH-NH, Zarit)
Blood pressure, pulse, frequency of stool, height, weight, degree of dementia (CDR), functional independence measurement (FIM), Mini-Mental State (MMSE), GDS, depressive state (PHQ9), oral examination, amount of saliva, cardiovascular and other vascular events, death by all cause
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Behavior,custom | Maneuver |
Oral myofunctional training program
60 | years-old | <= |
Not applicable |
Male and Female
1) Person who lives or visits regularly in Social Welfare Corporation Tsubakigaoka, an Intensive Care Home for the Elderly.
2) Person who is over 60 years old.
3) Dementia person
4) Person from whom informed consent is obtained by him/herself or key-person within the three degree of kinship.
1) Person who is mechanically-entilated.
2) Person who has serious conditions in the oral cavity
3) In case the doctor finds any difficulty for participation.
14
1st name | Tomomi |
Middle name | |
Last name | Ide |
Kyushu University Hospital
Department of Cardiovascular Medicine
8128582
3-1-1, Maidashi, Higashi-ku, Fukuoka
092-641-1151
tomomi_i@cardiol.med.kyushu-u.ac.jp
1st name | Tomomi |
Middle name | |
Last name | Ide |
FFC inc.
Business Promotion Unit
8510122
1-3-12, Sakai, Nagasaki-city
095-801-8023
info@ffc-p.jp
Kyushu University
None
Self funding
Japan
IRB, Tsubakigaoka
1553, maruo, Nagasaki
0959-24-0130
tubaki-i@dream.ocn.ne.jp
NO
社会福祉法人椿ヶ丘特別養護老人ホーム椿ヶ丘荘
2013 | Year | 08 | Month | 14 | Day |
Unpublished
No longer recruiting
2013 | Year | 08 | Month | 12 | Day |
2013 | Year | 08 | Month | 14 | Day |
2013 | Year | 12 | Month | 08 | Day |
2014 | Year | 06 | Month | 17 | Day |
2014 | Year | 06 | Month | 17 | Day |
2014 | Year | 07 | Month | 29 | Day |
2013 | Year | 08 | Month | 14 | Day |
2020 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013407
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