UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055389 |
|---|---|
| Receipt number | R000063260 |
| Scientific Title | Relationship between Body Cognitive Errors and Falls in Elderly People with Dementia in a Long-term Care Health Facility |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/01 06:39:05 |
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Basic information
Public title
Relationship between Body Cognitive Errors and Falls in Elderly People with Dementia in a Long-term Care Health Facility
Acronym
Relationship between Body Cognitive Errors and Falls in Elderly People with Dementia in a Long-term Care Health Facility
Scientific Title
Relationship between Body Cognitive Errors and Falls in Elderly People with Dementia in a Long-term Care Health Facility
Scientific Title:Acronym
Relationship between Body Cognitive Errors and Falls in Elderly People with Dementia in a Long-term Care Health Facility
Region
| Japan |
Condition
Condition
Older adults with cognitive impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the relationship between body recognition errors and falls in elderly dementia patients residing in a long-term care facility.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate the relationship between body recognition errors after admission to an elderly care facility and the subsequent occurrence of falls during the stay.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body recognition error(Imagined Basic Movement Scale - Basic Movement Scale)
(Imagined Standing test for Imbalance and Disequilibrium - Standing test for Imbalance and Disequilibrium)
Key secondary outcomes
Hasegawa dementia rating scale-revised
Dementia Behavior Disturbance Scale13
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Dementia residents whose scores on the Hasegawa dementia rating scale-revised are between 5 and 25 points.
Key exclusion criteria
unable to perform physical function assessments
obvious higher brain dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Okita |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara-ken
TEL
0745-54-1601
f4951873@kio.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara-ken
TEL
0745-54-1601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara-ken
Tel
0745-54-1601
f4951873@kio.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Longitudinal studies, including prospective studies from post-hospitalization evaluation to 3 months
Groups into falls and non-falls based on fall status during the first 3 months after admission and compare between groups
Management information
Registered date
| 2024 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063260
