UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036830 |
|---|---|
| Receipt number | R000041958 |
| Scientific Title | Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/05/23 15:45:06 |
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Basic information
Public title
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Acronym
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title:Acronym
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Region
| Japan |
Condition
Condition
patients with developmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Multi dimensional Scale for PDD and ADHD:MSPA, Achenbach System of Empirically Based Assessment Adult Self Report:ASR, Brief Assessment of Cognition in Schizophrenia: BACS, Self Efficacy for Community Life scale: SECL, Life Assessment Scale for Mental Ill: LASMI, and The Global Assessment of Functioning Scale: GAF after cognitive rehabilitation for 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive rehabilitation
Interventions/Control_2
twice a week, 6 months
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
it was judged a psychiatrist to patients with developmental disorder
Key exclusion criteria
intelligence quotient more than 70 by Wechsler Adult Intelligence Scale- Third Edition,exclude dementia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ohno |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL
086-462-1111
h-oono@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ohno |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL
086-462-1111
Homepage URL
h-oono@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
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
Kawasaki University of Medical Welfare
Address
288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
Tel
086-462-1111
h-oono@mw.kawasaki-m.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
川崎医科大学付属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
