UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054522 |
|---|---|
| Receipt number | R000062295 |
| Scientific Title | Investigation of characteristics in visual-spatial attention function in patients with dementia and their relationship to balance function. |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/05/31 06:49:07 |
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Basic information
Public title
Investigation of characteristics in visual-spatial attention function in patients with dementia and their relationship to balance function.
Acronym
Investigation of the characteristics of attentional function in patients with dementia and its relationship to balance function.
Scientific Title
Investigation of characteristics in visual-spatial attention function in patients with dementia and their relationship to balance function.
Scientific Title:Acronym
Visuo-spatial attentional function and balance in people with dementia.
Region
| Japan |
Condition
Condition
People with dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate the characteristics of visuospatial attentional function in people with dementia and whether visual-spatial attentional function is associated with balance function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of visuospatial attentional function (modified-Posner task)
Assessment of the subjective visual vertical axis
Assessment of dynamic balance function (Time up and go)
Key secondary outcomes
Prefrontal cortex activity during a dynamic balance task using a portable brain activity measurement device.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those with a psychiatrist's diagnosis of Alzheimer's disease, Lewy body dementia, frontotemporal dementia or cerebrovascular dementia 2) Those with a Mini-Mental State Examination (MMSE) score of 16 or more 3) Those who are ambulatory with at least a watchful eye
Key exclusion criteria
Exclude patients who 1) cannot understand the test instructions, 2) cannot perform the test, 3) require assistance to walk, 4) have severe concomitant paralysis, aphasia or visual impairment, or 5) are unable to walk independently due to cardiac or respiratory disease, lower limb amputation or pain.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Tanabe |
Organization
Hiroshima Cosmopolitan University
Division name
Faculty of Health Sciences
Zip code
731-3166
Address
3-2-1 Otsuka-higashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
tanabe@hcu.ac.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Tanabe |
Organization
Hiroshima Cosmopolitan University
Division name
Faculty of Health Sciences
Zip code
731-3166
Address
3-2-1 Otsuka-higashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
Homepage URL
tanabe@hcu.ac.jp
Sponsor or person
Institute
Hiroshima Cosmopolitan University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Cosmopolitan 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
Ethics Review Committee of Hiroshima Cosmopolitan University
Address
3-2-1 Otsuka-higashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-849-6883
tanabe@hcu.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 | 06 | Month | 14 | 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 | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062295
