UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063530 |
|---|---|
| Receipt number | R000072712 |
| Scientific Title | A survey of occupational therapists on assessment and intervention aimed at social participation for people with traumatic brain injury |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 16:39:11 |
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Basic information
Public title
Survey of acute-care occupational therapists practice toward social participation of patients with traumatic brain injury
Acronym
Survey of acute-care occupational therapists practice toward social participation of patients with traumatic brain injury
Scientific Title
A survey of occupational therapists on assessment and intervention aimed at social participation for people with traumatic brain injury
Scientific Title:Acronym
A survey of occupational therapists on assessment and intervention aimed at social participation for people with traumatic brain injury
Region
| Japan |
Condition
Condition
Occupational therapist working at an acute-care hospital specializing in higher brain dysfunction following traumatic brain injury
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current practice of assessment and intervention targeting participation in the ICF for patients with cognitive impairment after traumatic brain injury among occupational therapists working in acute-care hospitals.
Basic objectives2
Others
Basic objectives -Others
To identify barriers and facilitators to such practice at the individual, institutional, and system levels.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of occupational therapists who implemented interventions targeting ICF participation within the past 6 months
Key secondary outcomes
Implementation rate of participation-focused assessment and tools used; intervention content; perceived importance of participation-focused approaches in acute care (5-point scale); barriers and facilitators; differences in respondent characteristics by recruitment route (mail vs. SNS); practice patterns (latent class analysis); free-text analysis
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
Occupational therapists working in acute-care hospitals who have treated at least one patient with cognitive impairment after traumatic brain injury within the past year
Key exclusion criteria
1. Individuals without an occupational therapist license; 2. Individuals who do not consent to participate
Target sample size
300
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
Takayuki Miyauchi
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2027 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Invitations are mailed to approximately 500 acute-care hospitals selected from the facility list of the Japanese Association of Occupational Therapists, and participants are also recruited via X, Facebook, and Instagram. The anonymous online survey uses Google Forms and takes about 15 minutes. The study is explained on the first screen, and submission is regarded as consent. The response period is approximately one month from the mailing date.
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=R000072712
