UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031583 |
|---|---|
| Receipt number | R000036064 |
| Scientific Title | Effect of intervention on social life for people with higher brain dysfunction in the community - Study using single case design - |
| Date of disclosure of the study information | 2018/03/05 |
| Last modified on | 2023/01/23 10:20:58 |
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Basic information
Public title
Effect of intervention on social life for people with higher brain dysfunction in the community
- Study using single case design -
Acronym
Effect of intervention on social life for people with higher brain dysfunction in the community
Scientific Title
Effect of intervention on social life for people with higher brain dysfunction in the community
- Study using single case design -
Scientific Title:Acronym
Effect of intervention on social life for people with higher brain dysfunction in the community
Region
| Japan |
Condition
Condition
Stroke,Traumatic Brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intervention in activities for which higher brain dysfunction who have problems with higher brain functions such as memory impairment and performance impairment or their families want to become independent in social life or problem behavior which they want to reduce , And to clarify the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Target Behavior
Key secondary outcomes
Neuropsychological findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Errorless learning
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cognitive disorder in the community
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Hyogo Medical University
Division name
School of Rehabilitation
Zip code
6508530
Address
1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan
TEL
078-304-3091
da-shimizu@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Hyogo University of Health Scienes
Division name
School of Rehabilitation
Zip code
6508530
Address
1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan
TEL
078-304-3091
Homepage URL
da-shimizu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo University of Health Scienes
Institute
Department
Personal name
Funding Source
Organization
Hyogo University of Health Scienes
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo medical University
Address
1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan
Tel
078-304-3091
da-shimizu@hyo-med.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
| 2018 | Year | 03 | Month | 05 | 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
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036064
