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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028534
Receipt No. R000032642
Scientific Title Approach for the introduction into the training package that incorporated a viewpoint of an occupational therapy in the working activity.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/02/06

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Basic information
Public title Approach for the introduction into the training package that incorporated a viewpoint of an occupational therapy in the working activity.
Acronym Approach for the introduction into the training package that incorporated a viewpoint of an occupational therapy in the working activity.
Scientific Title Approach for the introduction into the training package that incorporated a viewpoint of an occupational therapy in the working activity.
Scientific Title:Acronym Approach for the introduction into the training package that incorporated a viewpoint of an occupational therapy in the working activity.
Region
Japan

Condition
Condition cerebrovascular disease, brain injury, encephalitis, spinal injury, cerebral arteriovenous malformations
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We can compose a degree of difficulty of the work by making the training package which incorporated a viewpoint of the occupational therapy, and grasp a change of the performance after the training more definitely.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Working speed, the level of achievement, the number of mistakes, etc.
Key secondary outcomes Questionnaires for the subjects (contents of the work, difficulty, etc.)
Questionnaires for the supporters (contents of the work, easiness of operation, etc.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 For the assembly and the sorting work, we make lists of works that described the order of the tasks.
The subjects work along the lists, and we record the required time and the results.
The subjects carry out the works 2 times, and we compare the change (working speed, the number of mistakes, etc.) between the first and the second implementation.
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Users of support facilities for persons with disabilities which newly start the working activity.
Key exclusion criteria Persons who cannot recognize the instructions by reason of severe cognitive impairment.
Persons who cannot carry out the series of working activities 2 times.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Namie Sugiyama
Organization Nagoya City Rehabilitation Agency
Division name Department of Services and Supports for Persons with Disabilities
Zip code
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email sisetu1@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Namie Sugiyama
Organization Nagoya City Rehabilitation Agency
Division name Department of Services and Supports for Persons with Disabilities
Zip code
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email sisetu1@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization none
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
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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032642

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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