UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030140 |
|---|---|
| Receipt number | R000034288 |
| Scientific Title | Cognitive rehabilitation program for Neurodevelopmental Disorders |
| Date of disclosure of the study information | 2017/11/29 |
| Last modified on | 2024/06/03 11:18:07 |
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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
Changes in endogenous oxytocin concentrations
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
30
Research contact person
Name of lead principal investigator
| 1st name | Hidehiro |
| Middle name | |
| Last name | Umehara |
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
umehara.hidehiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiro |
| Middle name | |
| Last name | Umehara |
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
umehara.hidehiro@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
| 2026 | 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
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034288
