UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the usefulness of occupational therapy program using quantitative evaluation of mental function and autonomic function
Title of the study (Brief title)	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	Ken okutani
Organization	Hyogo university of Health Science
Division name	Graduate School of Applied Informatics
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	Ken okutani
Organization	Hyogo university of Health Science
Division name	Graduate School of Applied Informatics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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