UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031581
Receipt number R000036058
Scientific Title A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/05 12:59:12

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Basic information

Public title

A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function

Acronym

A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function

Scientific Title

A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function

Scientific Title:Acronym

A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function

Region

Japan


Condition

Condition

Mental disorder

Classification by specialty

Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It aims to examine the usefulness of occupational therapy by evaluating the influence of occupational therapy intervention on mental function and autonomic nervous function which strengthens confidence by achieving gradual work activity for mentally handicapped persons.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Brief Objective Measures

Key secondary outcomes

General Self-Efficacy Scale,Profile of Mood State,Digital Plethysmogram,Brief Psychiatric Rating Scale.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The subjects were supposed to carry out a stencil activity therapy. In Group1,the subjects were intervened by a therapist to assist their activities

Interventions/Control_2

while in Group2,the subjects had to complete their activities by trial and error.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The subject of this study was assumed to be over 20 years old, mentally disabled, and attending facilities operated by a specified nonprofit corporation. In addition, it was assumed that the person who was responsible for the facility judged that the subject could participate in the occupational therapy program formulated by the research organization, and agreed with the research.

Key exclusion criteria

Those judged to be unable to participate in facility managers at research facilities. Those whose consent to the research of the subject could not be obtained.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken okutani

Organization

Hyogo university of Health Science

Division name

Graduate School of Applied Informatics

Zip code


Address

1-3-6 Minatojima Chuo-ku Kobe 650-8530 apan

TEL

078-304-3141

Email

okutani@huhs.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken okutani

Organization

Hyogo university of Health Science

Division name

Graduate School of Applied Informatics

Zip code


Address

Graduate School of Applied Informatics

TEL

078-304-3141

Homepage URL


Email

okutani@huhs.ac.jp


Sponsor or person

Institute

Hyogo university of Health Science

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Designated nonprofit corporation Hayashisu

Graduate School of Applied Informatics University of Hyogo

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

指定非営利法人 ひやしんす(兵庫県)


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

In the intervention group, sympathetic nerves suppressed and parasympathetic nerves were thought to have worked by having worked with confidence by occupational therapy intervention. In the intervention group, the random test was significantly improved and the self-efficacy was also significantly improved in the Takana simple mental function test. Based on the results of this study, it is considered that parasympathetic nerves acted dominantly by reducing the anxiety about the activity by the occupational therapy intervention which achieves gradual work activity and strengthens confidence.

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 09 Month 13 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2018 Year 03 Month 05 Day

Date of closure to data entry

2018 Year 03 Month 05 Day

Date trial data considered complete

2018 Year 03 Month 05 Day

Date analysis concluded

2018 Year 03 Month 05 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 05 Day

Last modified on

2018 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name