UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027788 |
|---|---|
| Receipt number | R000031830 |
| Scientific Title | Search of the effective cognitive rehabilitation program with the portable brain activity measurement device |
| Date of disclosure of the study information | 2017/06/17 |
| Last modified on | 2017/06/17 08:54:47 |
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Basic information
Public title
Search of the effective cognitive rehabilitation program with the portable brain activity measurement device
Acronym
Search of the effective cognitive rehabilitation program
Scientific Title
Search of the effective cognitive rehabilitation program with the portable brain activity measurement device
Scientific Title:Acronym
Search of the effective cognitive rehabilitation program
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We demonstrate an effect of the cognitive rehabilitation by visualizing the influence on a non-pharmacological therapy on the brain using a portable brain activity measurement device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We measure the brain blood flow by fNIRS while carrying out a usual cognitive rehabilitation program (painting, origami, a crossword puzzle, and calculation). The intervention
program will be carried out four times at a month for around 30 minutes at one time.
Interventions/Control_2
We measure the brain blood flow by fNIRS while carrying out the program which encourage cognitive functions such as language memory, the concentration, a working memory, a practice function, and the transaction speed. The intervention program will be carried out four times at a month for around 30 minutes at one time.
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
In elderly people 65 years or older, we assume it the person who does not interfere with their daily life in eyesight, a hearing ability,
and verbal ability.
Key exclusion criteria
An elderly person with highly advanced brain functional disorder such as after a mental disease or cerebral infarction will exclude.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kubota Masakazu |
Organization
Osaka Medical College
Division name
Graduate School of Nursing
Zip code
Address
7-6 Hcchonishi-machi, Takatsuki-City, Osaka
TEL
072-684-7223
fon153@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kubota Masakazu |
Organization
Osaka Medical College
Division name
Graduate School of Nursing
Zip code
Address
7-6 Hcchonishi-machi, Takatsuki-City, Osaka
TEL
072-684-7223
Homepage URL
fon153@osaka-med.ac.jp
Sponsor or person
Institute
Graduate School of Nursing, Osaka Medical college
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2017 | Year | 06 | Month | 17 | 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
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031830
| 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 |
