UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031583
Receipt number R000036064
Scientific Title Effect of intervention on social life for people with higher brain dysfunction in the community - Study using single case design -
Date of disclosure of the study information 2018/03/05
Last modified on 2023/01/23 10:20:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of intervention on social life for people with higher brain dysfunction in the community
- Study using single case design -

Acronym

Effect of intervention on social life for people with higher brain dysfunction in the community

Scientific Title

Effect of intervention on social life for people with higher brain dysfunction in the community
- Study using single case design -

Scientific Title:Acronym

Effect of intervention on social life for people with higher brain dysfunction in the community

Region

Japan


Condition

Condition

Stroke,Traumatic Brain injury

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Intervention in activities for which higher brain dysfunction who have problems with higher brain functions such as memory impairment and performance impairment or their families want to become independent in social life or problem behavior which they want to reduce , And to clarify the effect.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Target Behavior

Key secondary outcomes

Neuropsychological findings


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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Errorless learning

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

Cognitive disorder in the community

Key exclusion criteria

none

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Shimizu

Organization

Hyogo Medical University

Division name

School of Rehabilitation

Zip code

6508530

Address

1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan

TEL

078-304-3091

Email

da-shimizu@hyo-med.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Shimizu

Organization

Hyogo University of Health Scienes

Division name

School of Rehabilitation

Zip code

6508530

Address

1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan

TEL

078-304-3091

Homepage URL


Email

da-shimizu@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo University of Health Scienes

Institute

Department

Personal name



Funding Source

Organization

Hyogo University of Health Scienes

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kobe University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo medical University

Address

1-3-6 minatojima, chuou-ku, kobe, 650-8530, japan

Tel

078-304-3091

Email

da-shimizu@hyo-med.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

2018 Year 03 Month 05 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

Enrolling by invitation

Date of protocol fixation

2018 Year 02 Month 05 Day

Date of IRB

2021 Year 08 Month 25 Day

Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2024 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

2018 Year 03 Month 05 Day

Last modified on

2023 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name