UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050472 |
|---|---|
| Receipt number | R000057486 |
| Scientific Title | Efficacy of Pre-Rehabilitation in Patients with Total Knee Arthroplasty - Non-Randomized Trial - |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2024/03/15 20:09:30 |
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Basic information
Public title
Efficacy of Pre-Rehabilitation in Patients with Total Knee Arthroplasty - Non-Randomized Trial -
Acronym
Efficacy of Pre-Rehabilitation in Patients with Total Knee Arthroplasty - Non-Randomized Trial -
Scientific Title
Efficacy of Pre-Rehabilitation in Patients with Total Knee Arthroplasty - Non-Randomized Trial -
Scientific Title:Acronym
Efficacy of Pre-Rehabilitation in Patients with Total Knee Arthroplasty - Non-Randomized Trial -
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify efficacy of Pre-Rehabilitation in patients with total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Kinetics and kinematics parameters during gait
Period: At the start of preoperative rehabilitation, at the end of preoperative rehabilitation, 1 month after surgery (at discharge), 3 months after surgery
Key secondary outcomes
Pain(NRS)
Health-related quality of life (WOMAC, KOOS, KSS)
Range of motion (knee)
Isometric lower limb muscle strength (knee extensor strength, hip abductor strength)
Performance Test (30 second Chair Stand Test, Stair Climb Test, 40m Fast Paced Walk Test)
Lower limb alignment (K L classification, FTA, mechanical axis)
Period: At the start of preoperative rehabilitation, at the end of preoperative rehabilitation, 1 month after surgery (at discharge), 3 months after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Maneuver |
Interventions/Control_1
Pre-Rehabilitation Group
exercise:Ultrasound therapy, resistance training, weight bearing exercises, ergometer
period:Two times a week for two months
Interventions/Control_2
ControlGroup
exercise:without treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for first total knee arthroplasty at a single institution
Able to participate in rehabilitation two times a week
Key exclusion criteria
Cerebrovascular disease,intractable neurological disease
Severe heart disease
Severe dementia
Unable to walk
Rheumatoid arthritis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | shomaru |
| Middle name | |
| Last name | ito |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Rehabilitation
Zip code
286-0124
Address
852, Hatakeda, Narita City, Chiba, 286-8520, Japan
TEL
0476-35-5600
shomaru.ito@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | shomaru |
| Middle name | |
| Last name | ito |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Rehabilitation
Zip code
286-0124
Address
852, Hatakeda, Narita City, Chiba, 286-8520, Japan
TEL
0476-35-5600
Homepage URL
shomaru.ito@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
none
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
International University of Health and Welfare IRB
Address
852, Hatakeda, Narita City, Chiba, 286-8520, Japan
Tel
0476-35-5607
iuhw-irb@iuhw.ac.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
| 2023 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057486
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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