UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047110
Receipt number R000053740
Scientific Title Fine motor function in schizophrenics.
Date of disclosure of the study information 2022/03/08
Last modified on 2022/03/07 20:06:56

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Basic information

Public title

Fine motor function in schizophrenics.

Acronym

Fine motor function in schizophrenics.

Scientific Title

Fine motor function in schizophrenics.

Scientific Title:Acronym

Fine motor function in schizophrenics.

Region

Japan


Condition

Condition

schizophrenics

Classification by specialty

Psychiatry Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify the relationship between symptoms and fine motor function in schizophrenics.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive and Negative Syndrome Scale
WHODAS 2.0
Sensory Profile Short Version
finger-nose test
Internal - external ileum test

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults 20 years of age or older with no history of mental illness
Hospital and institutionalized schizophrenics

Key exclusion criteria

Patients who do not understand the test
Patients with strong feelings of hopelessness
Patients with depression clearly caused by personality disorders
Other patients deemed inappropriate by the investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name shin
Middle name
Last name Kataoka

Organization

Graduate School of Health Science, Kio University

Division name

Graduate School of Health Science, Kio University

Zip code

635-0832

Address

(4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

TEL

0745-54-1601

Email

f1995138@kio.ac.jp


Public contact

Name of contact person

1st name Shin
Middle name
Last name Kataoka

Organization

Graduate School of Health Science, Kio University

Division name

Graduate School of Health Science, Kio University

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

TEL

0745-54-1601

Homepage URL


Email

f1995138@kio.ac.jp


Sponsor or person

Institute

Graduate School of Health Science, Kio University

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Health Science, Kio University

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

Tel

0745-54-1601

Email

f1995138@kio.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

2022 Year 03 Month 08 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

2022 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2022 Year 04 Month 02 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Before start


Management information

Registered date

2022 Year 03 Month 07 Day

Last modified on

2022 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053740