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 2023/11/14 10:06:01

* 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

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

Email

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


Email

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

Email

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

2026 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

2023 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041827


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name