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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000036830 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | patients with developmental disorder | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | it was judged a psychiatrist to patients with developmental disorder
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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 |
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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 |
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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 | |
Institute | Kawasaki University of Medical Welfare Department of Occupational Therapy |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041958 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |