UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063529 |
|---|---|
| Receipt number | R000072711 |
| Scientific Title | Reconsidering undergraduate education on higher brain dysfunction |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 16:23:18 |
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Basic information
Public title
A longitudinal survey of occupational therapy students perceptions of higher brain dysfunction
Acronym
A longitudinal survey of occupational therapy students perceptions of higher brain dysfunction
Scientific Title
Reconsidering undergraduate education on higher brain dysfunction
Scientific Title:Acronym
Reconsidering undergraduate education on higher brain dysfunction
Region
| Japan |
Condition
Condition
Healthy volunteers (occupational therapy students)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify occupational therapy students perceptions of higher brain dysfunction, and how these perceptions differ by academic performance (GPA) and change before and after clinical placements.
Basic objectives2
Others
Basic objectives -Others
To identify gaps between classroom learning and clinical practice and factors that foster students interest in higher brain function, in order to reconsider undergraduate teaching methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in perceptions of higher brain dysfunction (questionnaire items) across three time points
Key secondary outcomes
Differences in perceptions by GPA group; gap between classroom and clinical learning and related factors; factors associated with interest in higher brain function; text-mining results of free descriptions
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Students of the Occupational Therapy Course, Department of Rehabilitation, Shonan University of Medical Sciences, who are in their third or fourth year between academic years 2025 and 2029; 2. Students who have taken the course on higher brain dysfunction; 3. Students who have completed or are expected to complete the clinical placement (for post-placement surveys); 4. Students who agree to participate
Key exclusion criteria
Students who do not agree to participate (non-respondents)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Occupational Therapy Course, Department of Rehabilitation, Faculty of Health Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458210111
takayuki.miyauchi@sums.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Occupational Therapy Course, Department of Rehabilitation, Faculty of Health Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458210111
Homepage URL
takayuki.miyauchi@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Shonan University of Medical Sciences
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
Shonan University of Medical Sciences
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
0458210111
takayuki.miyauchi@sums.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
| 2026 | Year | 11 | 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
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
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An anonymous web-based questionnaire (Google Forms) is administered three times per participant. The study is explained on the first screen, and submission of the questionnaire is regarded as consent. Because the data are anonymous, consent cannot be withdrawn.
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072711
