UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062495 |
|---|---|
| Receipt number | R000071533 |
| Scientific Title | Verification of the Effectiveness of Goal-Oriented Occupational Therapy Based on Cognitive Behavioral Therapy |
| Date of disclosure of the study information | 2026/08/06 |
| Last modified on | 2026/08/06 12:14:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Goal-Oriented Occupational Therapy Based on Cognitive Behavioral Therapy on Pain, Psychological Factors, and Physical Activity
Acronym
Verification of the Effectiveness of Goal-Oriented Occupational Therapy Based on Cognitive Behavioral Therapy
Scientific Title
Verification of the Effectiveness of Goal-Oriented Occupational Therapy Based on Cognitive Behavioral Therapy
Scientific Title:Acronym
Verification of the Effectiveness of Goal-Oriented Occupational Therapy Based on Cognitive Behavioral Therapy
Region
| Japan |
Condition
Condition
Patients after total knee arthroplasty
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial aims to clarify the effects on pain, psychological factors, and physical activity levels of combining goal-oriented occupational therapy based on cognitive-behavioral theory with standard inpatient rehabilitation, compared to standard rehabilitation alone, in patients who have undergone total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale (NRS)
Key secondary outcomes
Pain Catastrophizing Scale (PCS)
Hospital Anxiety and Depression Score (HADS)
Pain Self efficacy Questionnaire (PSEQ)
physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Goal-oriented occupational therapy based on standard rehabilitation plus cognitive behavioral therapy.
Interventions/Control_2
Standard rehabilitation
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are patients undergoing total knee arthroplasty for knee osteoarthritis.
Key exclusion criteria
Patients who underwent total knee arthroplasty for diagnoses other than knee osteoarthritis.
Individuals presenting with dementia or mental disorders.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hiraga |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medicine
Zip code
8140001
Address
Momochihama, Sawara Ward, Fukuoka City
TEL
8140001
hiraga@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hiraga |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Medicine
Zip code
8140001
Address
Momochihama, Sawara Ward, Fukuoka Cit
TEL
0928321200
Homepage URL
hiraga@takagigakuen.ac.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Fukuoka International University of Health and Welfare
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
Momochihama, Sawara Ward, Fukuoka City
Tel
0928321200
hiraga@takagigakuen.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 | 08 | Month | 06 | 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 | 08 | Month | 06 | Day |
Date of IRB
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
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071533
