UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040701 |
|---|---|
| Receipt number | 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 | 2020/12/09 09:22:58 |
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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
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
japan.reha2018@gmail.com
Sponsor or person
Institute
Social welfare corporation Fujimikai
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045568
