UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028175
Receipt number R000032256
Scientific Title Analysis about a factor affecting the inference of right hemisphere damage patients
Date of disclosure of the study information 2017/08/01
Last modified on 2021/04/05 12:27:01

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Basic information

Public title

Analysis about a factor affecting the inference of right hemisphere damage patients

Acronym

Language function of right hemisphere damage patients

Scientific Title

Analysis about a factor affecting the inference of right hemisphere damage patients

Scientific Title:Acronym

Language function of right hemisphere damage patients

Region

Japan


Condition

Condition

brain damage

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

I perform the evaluation for the communication disorder to occur because of the right hemisphere damage and I examine the usefulness.

Basic objectives2

Others

Basic objectives -Others

I clarify obstacle structure of the communication by the right hemisphere damage.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

discourse analysis rating scales

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

inference test
discourse analysis rating scales
narrative story
wais3(Picture Completion)

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

40 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

right hemisphere damage

Key exclusion criteria

both sides of brain damage

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Rie
Middle name
Last name Rie Uetani

Organization

Kawasaki University of Medical Welfare

Division name

department of sensory science

Zip code

7010193

Address

288,Matsushima,Kurashiki,Okayama

TEL

086-462-1111

Email

uetani@mw.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Uetani

Organization

Kawasaki University of Medical Welfare

Division name

department of sensory science

Zip code

7010193

Address

288,Matsushima,Kurashiki,Okayama

TEL

086-462-1111

Homepage URL


Email

uetani@mw.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki University of Medical Welfare

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,Okayama

Tel

086-462-1111

Email

kenkyu@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



Other administrative information

Date of disclosure of the study information

2017 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

33

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

Completed

Date of protocol fixation

2017 Year 07 Month 11 Day

Date of IRB

2017 Year 12 Month 11 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 11 Day

Last modified on

2021 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032256


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name