UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014974 |
|---|---|
| Receipt number | R000017409 |
| Scientific Title | Effectiveness of using a hybrid assistive limb (HAL) after total knee arthroplasty (TKA) |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2015/08/28 17:47:38 |
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Basic information
Public title
Effectiveness of using a hybrid assistive limb (HAL) after total knee arthroplasty (TKA)
Acronym
Effectiveness of using HAL after TKA
Scientific Title
Effectiveness of using a hybrid assistive limb (HAL) after total knee arthroplasty (TKA)
Scientific Title:Acronym
Effectiveness of using HAL after TKA
Region
| Japan |
Condition
Condition
After total knee arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of HAL after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 Meter Walk Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
20 minutes physical therapy wearing a hybrid assistive limb in addition to the 20 minutes conventional physical therapy, from day 4 to day 18 postsurgery
Interventions/Control_2
40 minutes conventional physical therapy per day
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing primary total knee arthroplasty for osteoarthritis aged 65 to 85 years
Key exclusion criteria
rheumatoid arthritis, revision TKA, stroke, malignant tumor, Parkinson's disease, dementia, active infection, pulmonary embolism, deep vein thrombosis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Tanaka |
Organization
JR TOKYO GENERAL HOSPITAL
Division name
Department of Rehabilitation
Zip code
Address
2-1-3, Yoyogi, Shibuya-ku, Tokyo
TEL
03-3320-2200
youheitanaka@jreast.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Tanaka |
Organization
JR TOKYO GENERAL HOSPITAL
Division name
Department of Rehabilitation
Zip code
Address
2-1-3, Yoyogi, Shibuya-ku, Tokyo
TEL
03-3320-2200
Homepage URL
youheitanaka@jreast.co.jp
Sponsor or person
Institute
JR TOKYO GENERAL HOSPITAL Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2014 | Year | 09 | Month | 08 | 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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | 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
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017409
