UMIN-ICDS 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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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