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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031583
Receipt No. 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 2018/03/05

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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
Middle name
Last name Shimizu Daisuke
Organization Hyogo University of Health Scienes
Division name School of Rehabilitation
Zip code
Address 1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan
TEL 078-304-3091
Email da-shimizu@huhs.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shimizu Daisuke
Organization Hyogo University of Health Scienes
Division name School of Rehabilitation
Zip code
Address 1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan
TEL 078-304-3091
Homepage URL
Email da-shimizu@huhs.ac.jp

Sponsor
Institute Hyogo University of Health Scienes
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 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
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036064

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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