UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060345 |
|---|---|
| Receipt number | R000069034 |
| Scientific Title | Development of the Japanese version of the Physiotherapist Self-Efficacy questionnaire: an international collaborative study |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/14 00:38:31 |
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Basic information
Public title
Development of a self-efficacy scale for clinical skills in physical therapists
Acronym
Development of a self-efficacy scale for clinical skills in physical therapists
Scientific Title
Development of the Japanese version of the Physiotherapist Self-Efficacy questionnaire: an international collaborative study
Scientific Title:Acronym
Development of the Japanese version of the Physiotherapist Self-Efficacy questionnaire: an international collaborative study
Region
| Japan |
Condition
Condition
Undergraduate students majoring in physical therapy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop the Japanese version of the Physiotherapist Self-Efficacy questionnaire and to assess its psychometric properties.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Physiotherapist Self-Efficacy questionnaire score
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For the pretest
- Second-year students
- Native speakers of Japanese
- Individuals who have provided informed consent to participate in the study
For the evaluation of psychometric properties (Item Analysis, Structural Validity, Internal Consistency, Relationships with Existing Scales, and Test-Retest Reliability)
- Students from all academic years
- Native speakers of Japanese
- Individuals who have been enrolled in the training school for 5 months or longer
- Individuals who have provided informed consent to participate in the study
For the evaluation of psychometric properties (responsiveness)
- Individuals expected to participate in clinical practice
- Native speakers of Japanese
- Individuals who have provided informed consent to participate in the study
Key exclusion criteria
For the pretest
- Individuals who require special assistance in completing the scale due to impaired physical or mental functions (e.g., visual, auditory, or upper limb dysfunction)
- Individuals who are on a leave of absence during the study period
For the evaluation of psychometric properties (Item Analysis, Structural Validity, Internal Consistency, Relationships with Existing Scales, and Test-Retest Reliability)
- Individuals who meet the exclusion criteria defined for the pre-test
- Individuals who participated in the pre-test
For the evaluation of psychometric properties (responsiveness)
- Individuals who meet the exclusion criteria defined for the pre-test
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
k_oyake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Singapore Institute of Technology
Research Institute, National Rehabilitation Center for Persons with Disabilities
Kitasato University
Nagano University of Health and Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Life Sciences and Medicine at Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-3099
mdrinri@shinshu-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
信州大学（長野県）、長野保健医療大学（長野県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | 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 | 01 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-test: Participants were asked to evaluate the clarity of the items in the Japanese version of the Physiotherapist Self-Efficacy questionnaire (pre-test version). First, participants completed the questionnaire online via Google Forms (Google LLC, Mountain View, CA, USA). Subsequently, interviews were conducted regarding the clarity of the questions. Based on the feedback obtained during the pre-test, the wording was revised to finalize the questionnaire.
Psychometric Evaluation (Item Analysis, Structural Validity, Internal Consistency, Relationships with Existing Scales, and Test-Retest Reliability): To evaluate item analysis, structural validity, internal consistency, and relationships with existing scales, participants will be asked to complete the Japanese version of the Physiotherapist Self-Efficacy questionnaire, along with the General Self-Efficacy Scale and the Compound Psychological Capital Scale as concurrent measures. Furthermore, to assess the test-retest reliability of the Japanese version of the Physiotherapist Self-Efficacy questionnaire, participants will be invited to complete the questionnaire again within one week of the initial assessment.
Psychometric Evaluation (Responsiveness): To evaluate the responsiveness of the scale, participants will be asked to complete the Japanese version of the Physiotherapist Self-Efficacy questionnaire before and after their clinical practice. Furthermore, as a sensitivity analysis, we will examine the relationships of the responsiveness with clinical practice grades and differences between the participating institutions.
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069034
