UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050744 |
|---|---|
| Receipt number | R000057819 |
| Scientific Title | Survey of Orthotic Therapy in Japan and Comparison of Before and After Intervention: Prospective and retrospective observational study and A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/04/02 |
| Last modified on | 2024/04/05 10:03:29 |
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Basic information
Public title
Pre- and post-graduate questionnaires and randomized controlled trials in orthotic therapy
Acronym
Pre- and post-graduate questionnaires and randomized controlled trials in orthotic therapy
Scientific Title
Survey of Orthotic Therapy in Japan and Comparison of Before and After Intervention: Prospective and retrospective observational study and A Randomized Controlled Trial
Scientific Title:Acronym
Survey of Orthotic Therapy in Japan and Comparison of Before and After Intervention: Prospective and retrospective observational study and A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy adults and Stroke pstients
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A survey on the actual status of orthotic therapy in Japan was conducted at the Japan Physical Therapy Association in 2017. The survey revealed the importance of expanding pre-graduation education and post-graduation education for new graduates. However, six years have passed since then, and education before and after obtaining a physical therapist license is still insufficient. Therefore, the purpose of this study was to conduct a prospective cohort study and a randomized controlled trial to compare before and after surveys and educational interventions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire Survey
Self-efficacy
Satisfaction
Questionnaire
Randomized controlled trial
FAC
FIM
BBS
MMSE
BRS
FMA
mRS
10MWT
Key secondary outcomes
VAS
NRS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Availability of educational and OJT intervention
Interventions/Control_2
Availability of educational and OJT intervention
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
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students affiliated with the University, post-graduate physiotherapists living in the area, and stroke cases
Key exclusion criteria
In case of mid-stay interruption complaints, or if neurological and orthopedic procedures are required during the hospitalization period, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Ryotokuji University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu, Chiba, Japan
TEL
+818012079205
koutas966@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Ryotokuji University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu, Chiba, Japan
TEL
+818012079205
Homepage URL
koutas966@gmail.com
Sponsor or person
Institute
Ryotokuji University
Institute
Department
Personal name
Funding Source
Organization
Ryotokuji University
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
Ryotokuji University
Address
5-8-1, Akemi, Urayasu, Chiba, Japan, 279-8567
Tel
+818012079205
k-sawa@ryotokuji-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
| 2023 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 02 | 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
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057819
| Research Plan | |
|---|---|
| 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 |
