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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030140
Receipt No. R000034288
Scientific Title Cognitive rehabilitation program for Neurodevelopmental Disorders
Date of disclosure of the study information 2017/11/29
Last modified on 2019/06/04

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Basic information
Public title Cognitive rehabilitation program for Neurodevelopmental Disorders
Acronym Cognitive rehabilitation program for Neurodevelopmental Disorders
Scientific Title Cognitive rehabilitation program for Neurodevelopmental Disorders
Scientific Title:Acronym Cognitive rehabilitation program for Neurodevelopmental Disorders
Region
Japan

Condition
Condition Neurodevelopmental Disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The verification of the intervention effect with the cognitive rehabilitation for Neurodevelopmental Disorders by cognitive function test and questionnaire survey method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function before and 12 weeks after the intervention.
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Rehabilitation once a week for 12 weeks
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 Patients with Neurodevelopmental disorder and Caregivers was diagnosed according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)
Key exclusion criteria 1.Sever psychiatric state
2.Sever intellectual disability
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tetsuro
Middle name
Last name Ohmori
Organization Graduate School of Biomedical Sciences, Tokushima University
Division name Department of Psychiatry
Zip code 770-8503
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7130
Email ohmori@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Tetsuro
Middle name
Last name Ohmori
Organization Graduate School of Biomedical Sciences, Tokushima University
Division name Department of Psychiatry
Zip code 770-8503
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7130
Homepage URL
Email ohmori@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Department of Psychiatry,Graduate School of Biomedical Sciences, Tokushima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization the institutional ethics committee of Tokushima University
Address 3-18-15 Kuramoto-cho, Tokushima
Tel 088-633-3298
Email first-ec@tokushima-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
2017 Year 11 Month 29 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 30 Day
Date of IRB
2017 Year 12 Month 25 Day
Anticipated trial start date
2018 Year 02 Month 01 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
2017 Year 11 Month 27 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034288

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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