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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027788
Receipt No. 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

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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
Email 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
Email fon153@osaka-med.ac.jp

Sponsor
Institute Graduate School of Nursing, Osaka Medical college
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031830

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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