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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034250
Receipt No. 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

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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
Email 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
Email nokopata_nokopata@yahoo.co.jp

Sponsor
Institute Fukuoka Rehabilitation Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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