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 2023/06/02 16:25:56

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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 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

Email

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


Email

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

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

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

2023 Year 06 Month 02 Day



Link to view the page

Value
https://center6.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