UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040935 |
|---|---|
| Receipt number | R000046733 |
| Scientific Title | Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty |
| Date of disclosure of the study information | 2020/06/29 |
| Last modified on | 2021/06/29 14:49:44 |
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Basic information
Public title
Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Acronym
Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Scientific Title
Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Scientific Title:Acronym
Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Region
| Japan |
Condition
Condition
hip osteoarthritis, knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to gait stability in patients before and after THA and TKA, and to examine the relationship between inter limb coordination with quality of life. Additionally, we investigate its association with other variables at each time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase coordination index and Harmonic ratio of the trunk acceleration (pre, 3weeks, 3months and 1year after surgery)
Key secondary outcomes
Quality of life(1year after surgery)
Lower limb strength(pre, 3weeks, 3months and 1year after surgery)
Lower limb angular velocity(pre, 3weeks, 3months and 1year after surgery)
Lower limb range of motion(pre, 3weeks, 3months and 1year after surgery)
Fall history(1year after surgery)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had total hip arthroplasty or total knee arthroplasty
The ability to walk 30 m or more without assistance
Key exclusion criteria
A participant was excluded if patients had any medical or neurological problem that would affect their ability to complete this trial, such as severe dementia, stroke, cardiac insufficiency, or acute respiratory failure.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Wanaka |
Organization
Kobe Rosai Hospital
Division name
Central Rehabilitation Department
Zip code
651-0053
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
078-231-5901
h.wanaka0531@gmail.com
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Wanaka |
Organization
Kobe Rosai Hospital
Division name
Central Rehabilitation Department
Zip code
651-0053
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
078-231-5901
Homepage URL
rosai@kobeh.johas.go.jp
Sponsor or person
Institute
Kobe Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Rosai Hospital
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
Tel
078-231-5901
rosai@kobeh.johas.go.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
| 2020 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
Patients admitted to the orthopedic department of Kobe Rosai Hospital, diagnosed with hip or knee OA and scheduled for THA and TKA.
Measurement items include demographics, phase coordination index, lower extremity muscle strength, lower extremity joint angular velocity, lower extremity joint range of motion, and pain.
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046733
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
