UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050654 |
|---|---|
| Receipt number | R000057713 |
| Scientific Title | Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients. |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/23 11:53:03 |
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Basic information
Public title
Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients.
Acronym
Examination of factors that contributed improvement of ADL and QOL with severe knee osteoarthritis patients.
Scientific Title
Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients.
Scientific Title:Acronym
Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients.
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients.
Basic objectives2
Others
Basic objectives -Others
Examination of factors that contributed improvement of ADL and QOL with moderate to severe knee osteoarthritis patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee Injury and Osteoarthritis Outcome Score
Key secondary outcomes
knee range of motion, knee extension muscle strength, gait speed, knee pain
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)>50 years of age, 2) moderate or severe OA.
Key exclusion criteria
1) lateral tibiofemoral KOA and 2) history of surgery in the lower limbs, spine, and pelvis.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Ohmine |
Organization
Faculty of Allied Health Sciences, Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences
Zip code
582-0026
Address
3-11-1 Asahigaoka, Kashiwara City, Osaka, Japan.
TEL
+81-72-978-0088
toshimitsu0605@gmail.com
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Ohmine |
Organization
Faculty of Allied Health Sciences, Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences
Zip code
582-0026
Address
3-11-1 Asahigaoka, Kashiwara City, Osaka, Japan.
TEL
+81-72-978-0088
Homepage URL
toshimitsu0605@gmail.com
Sponsor or person
Institute
Faculty of Allied Health Sciences, Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Shimada 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
Faculty of Allied Health Sciences, Kansai University of Welfare Sciences
Address
3-11-1 Asahigaoka, Kashiwara City, Osaka, Japan.
Tel
+81-72-978-0088
toshimitsu0605@gmail.com
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 | 23 | 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 | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conduct an initial assessment at the first response. A second evaluation will be performed after 3 months of physical therapy intervention. The KOOS-ADL and KOOS-QO of the first and second evaluations are compared and classified into those that have improved by 10 points or more and those that have not. Secondary outcomes will then be compared between the two groups.
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057713
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
