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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031581
Receipt No. 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

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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
Institute Hyogo university of Health Science
Institute
Department

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
URL(English) https://upload.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


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