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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040701
Receipt No. R000045568
Scientific Title Verification of brain task and standing rehabilitation program in day service -Evaluation of motivation, cognition and daily life-
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/09

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Basic information
Public title Verification of brain task and standing rehabilitation program in day service
-Evaluation of motivation, cognition and daily life-
Acronym Verification of brain task and standing rehabilitation program in day service
-Evaluation of motivation, cognition and daily life-
Scientific Title Verification of brain task and standing rehabilitation program in day service
-Evaluation of motivation, cognition and daily life-
Scientific Title:Acronym Verification of brain task and standing rehabilitation program in day service
-Evaluation of motivation, cognition and daily life-
Region
Japan

Condition
Condition Care insurance users







Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of intervention effect of developed brain task standing rehabilitation program
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daily life stand-up action
Key secondary outcomes Cognitive aspect
Intention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Research intervention period is 3 months
Standing rehabilitation program intervention
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 Approximately 50 people who are eligible for support 1-2, and in addition to those who are certified by Maebashi City as a care prevention/living support service project and can participate in the program at least once a week with the consent of the research
Key exclusion criteria Those who have cardiorespiratory system diseases or bone muscle disease systems and have difficulty standing up and sitting down
Those whose exercise or repetitive movements (standing-seating movements) have been canceled by a doctor
Those who do not get consent to participate in the research
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Youko
Middle name
Last name Uchida
Organization Gunma University Graduate School of Health Sciences
Division name Regional/International Nursing
Zip code 371-8514
Address Gunma Prefecture Maebashi City Showamachi 3- 39-22
TEL 027-220-7111
Email yuchida@gunma-u.ac.jp

Public contact
Name of contact person
1st name Tatsuo
Middle name
Last name Mineura
Organization Gunma University Graduate School of Health Sciences
Division name Regional/International Nursing Master's Program
Zip code 371-8514
Address Gunma Prefecture Maebashi City Showamachi 3- 39-22
TEL 027-220-7111
Homepage URL
Email japan.reha2018@gmail.com

Sponsor
Institute Social welfare corporation Fujimikai
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Research Ethics Review Committee for humans
Address Gunma Prefecture Maebashi City Showa Town 3-39-15
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-u.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
2020 Year 07 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
2020 Year 12 Month 31 Day
Date of IRB
2020 Year 01 Month 27 Day
Anticipated trial start date
2020 Year 01 Month 27 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 09 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045568

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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