UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028534 |
|---|---|
| Receipt number | 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 | 2020/08/06 10:17:48 |
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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 | Namie |
| Middle name | |
| Last name | Sugiyama |
Organization
Nagoya City Rehabilitation Agency
Division name
Department of Services and Supports for Persons with Disabilities
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
sisetu1@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Namie |
| Middle name | |
| Last name | Sugiyama |
Organization
Nagoya City Rehabilitation Agency
Division name
Department of Services and Supports for Persons with Disabilities
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
sisetu1@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.jp
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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032642
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
