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
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
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
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
