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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032567
Receipt No. 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 2018/05/15

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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
Institute University of Miyazaki Hospital
Institute
Department

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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 20 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 05 Month 12 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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