UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032567
Receipt number R000036931
Scientific Title A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.
Date of disclosure of the study information 2018/05/15
Last modified on 2022/06/08 12:51:34

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Basic information

Public title

A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.

Acronym

A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.

Scientific Title

A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.

Scientific Title:Acronym

A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A comparative study on the effect of continuous passive motion and Hybrid Assistive Limb (HAL) in Total Knee Arthroplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rang of motin 2weeks,3month,6month after
operation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ROM execise using HAL after operation

Interventions/Control_2

ROM execise using CPM after operation

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)patients over 55 years old
2)patients subjected to TKA for the first
time
3)patients who agree to particpate in this study

Key exclusion criteria

1)patients who are unable to waik over 10mby them selves
2)patients whose knee was subjects TKA
more than one time.
3)patients whose operation is planned
within 6 month.
4)patients who are unable to understand
simple explaination eg.demantia,higher
brain dysfunction or other causes.
5)patients with different mental and
physical other than mentioned above.
6)those who have a possibility of heavy
life crisis due to exercise,such as being forbidden by doctors
7)patients who are rejected to be taken
as resarch.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chousa Etsuo

Organization

University of Miyazaki Hospital

Division name

Rihabilitation

Zip code


Address

5200 Kihara Kiyotake-cho Miyazaki City

TEL

0985-85-1510

Email

medsomu@med.miyazaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ochiai Masaru

Organization

University of Miyazaki Hospital

Division name

Rihabilitation

Zip code


Address

5200 Kihara Kiyotake-cho Miyazaki City

TEL

0985-85-1510

Homepage URL


Email

masaru_ochiai@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki Hospital

Institute

Department

Personal name



Funding Source

Organization

University of Miyazaki Hospital

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 15 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

2018 Year 05 Month 20 Day

Date of IRB

2018 Year 05 Month 20 Day

Anticipated trial start date

2018 Year 05 Month 20 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 06 Month 08 Day

Date trial data considered complete

2022 Year 06 Month 08 Day

Date analysis concluded

2022 Year 06 Month 08 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 12 Day

Last modified on

2022 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036931


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name