UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034250 |
|---|---|
| Receipt number | R000039040 |
| Scientific Title | Effect of used on activity diary for occupational therapy practice has on the goal achievement, pain, psychological factors and physical activity for after total knee arthroplasty; a pilot study |
| Date of disclosure of the study information | 2018/09/24 |
| Last modified on | 2018/09/24 16:15:22 |
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Basic information
Public title
Effect of used on activity diary for occupational therapy practice has on the goal achievement, pain, psychological factors and physical activity for after total knee arthroplasty; a pilot study
Acronym
Study on occupational therapy practice using activity diary
Scientific Title
Effect of used on activity diary for occupational therapy practice has on the goal achievement, pain, psychological factors and physical activity for after total knee arthroplasty; a pilot study
Scientific Title:Acronym
Study on occupational therapy practice using activity diary
Region
| Japan |
Condition
Condition
Total knee arthroplasty
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effect of occupational therapy practice using "activity diary" for participants after TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome measures Canadian Occupational Performance Measure (COPM) and physical activity levels amount at the start and end of postoperative occupational therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
The activity diary is introduced only in the intervention group, and the subject records the daily step count, pain and comment.
Interventions/Control_2
Both intervention group and control group undergo normal occupational therapy 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
| 55 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Incorporation criteria were TKA from May 2014 to October 2016 in the medical institution to who carried out OT practice.
Key exclusion criteria
Exclusion criteria showed diagnosis of dementia and obvious mental illnesses (such as depression), making their own intros and questionnaire difficult
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Hiraga |
Organization
Fukuoka Rehabilitation Hospital
Division name
Rehabilitation department
Zip code
Address
770-7, Nokata, Fukuoka Nishi-ku, Fukuoka, japan
TEL
0928121880
nokopata_nokopata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Hiraga |
Organization
Fukuoka Rehabilitation Hospital
Division name
Rehabilitation department
Zip code
Address
770-7, Nokata, Fukuoka Nishi-ku, Fukuoka, japan
TEL
0928121880
Homepage URL
nokopata_nokopata@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
福岡リハビリテーション病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039040
