UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056424 |
|---|---|
| Receipt number | R000064475 |
| Scientific Title | Validation of scale characteristics of assessment of occupational balance for rehabilitation patients |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/12/11 10:12:21 |
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Basic information
Public title
Validation of scale characteristics of assessment of occupational balance for rehabilitation patients
Acronym
Validation of scale characteristics of assessment of occupational balance for rehabilitation patients
Scientific Title
Validation of scale characteristics of assessment of occupational balance for rehabilitation patients
Scientific Title:Acronym
Validation of scale characteristics of assessment of occupational balance for rehabilitation patients
Region
| Japan |
Condition
Condition
All diseases covered by rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify the occupational balance of rehabilitation patients and to determine the relationship between occupational balance adjustment and psychological problems.
Basic objectives2
Others
Basic objectives -Others
Validation of scale characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of Occupational Balance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Attributes of Study Subjects
(1) Gender: Any gender
(2)Age: Adults 18 years and older
(3)Inclusion criteria: Patients undergoing rehabilitation in a hospital or Facility
Key exclusion criteria
Exclusion criteria: Persons with impaired consciousness, aphasia with difficulty understanding explanations, cognitive dysfunction, etc., who are judged by the staff in charge to be unable to answer the self-administered questionnaire
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | ONDA |
Organization
Seijoh university
Division name
Department of Occupational Therapy, Faculty of Rehabilitation Studies
Zip code
4768588
Address
2-172, Fukinodai, Tokai, Aichi, Japan
TEL
0526016451
sonda@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | ONDA |
Organization
Seijoh university
Division name
Department of Occupational Therapy, Faculty of Rehabilitation Studies
Zip code
4768588
Address
2-172, Fukinodai, Tokai, Aichi, Japan
TEL
0526016451
Homepage URL
sonda@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh university
Institute
Department
Personal name
Funding Source
Organization
Seijoh university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh university
Address
2-172, Fukinodai, Tokai, Aichi, Japan
Tel
0526016451
sonda@seijoh-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 15 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The significance of this study is to develop occupational balance adjustment program by presenting the theoretical basis for such a program.
Management information
Registered date
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064475
