UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000036931
