UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036712 |
|---|---|
| Receipt number | R000041827 |
| Scientific Title | Impact of Occupational Therapy Intervention on Pain and Physical Function and Psychological Factors in Patients After High Tibial Osteotomy |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2025/05/14 09:22:24 |
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Basic information
Public title
Impact of Occupational Therapy on Pain and Physical Function and Psychological Factors in Patients After High Tibial Osteotomy
Acronym
Research on occupational therapy intervention
Scientific Title
Impact of Occupational Therapy Intervention on Pain and Physical Function and Psychological Factors in Patients After High Tibial Osteotomy
Scientific Title:Acronym
Study of occupational therapy intervention in patients after high tibial osteotomy
Region
| Japan |
Condition
Condition
Postoperative high tibial osteotomy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the efficacy of occupational therapy for patients after high tibial osteotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements measure pain and physical function and psychological factors preoperatively and at discharge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Occupational therapy is started only in the intervention group to promote goal achievement.
Interventions/Control_2
Perform regular physical therapy interventions in both the intervention group and the control group.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who has undergone high tibial osteotomy at the medical institution to which the first author belongs.
Key exclusion criteria
Exclusion criteria are 1) those who do not consent to occupational therapy, 2) those who present with systemic arthritic symptoms such as rheumatoid arthritis, 3) those who have psychiatric disorders such as schizophrenia, 4) stroke and Parkinson's disease, etc. Those who have neurosurgical disease of 5) who do not understand oral instructions.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiraga |
| Middle name | |
| Last name | Yuki |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medical Science
Zip code
814-0001
Address
3-6-40, Momochihama
TEL
092-832-1200
nokopata_nokopata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiraga |
| Middle name | |
| Last name | Yuki |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medical Science
Zip code
814-0001
Address
3-6-40, Momochihama
TEL
092-832-1200
Homepage URL
nokopata_nokopata@yahoo.co.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Non
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
Fukuoka International University of Health and Welfare
Address
3-6-40, Momochihama
Tel
092-832-1200
nokopata_nokopata@yahoo.co.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
| 2019 | Year | 05 | Month | 10 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041827
