UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033208 |
|---|---|
| Receipt number | R000037864 |
| Scientific Title | Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2018/06/30 08:09:48 |
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Basic information
Public title
Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis
Acronym
Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis
Scientific Title
Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis
Scientific Title:Acronym
Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait parameters, knee pain and Japanese Knee Osteoarthritis Measure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Knee varus instability-reducing shoes
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with knee osteoarthritis
Key exclusion criteria
Patients with Mini-Mental State Examination (MMSE) scores below 24, neurological, or psychiatric diseases that might influence the results, or inability to walk independently
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Murata |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Science
Zip code
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL
+81-75-571-1111
murata-s@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nakano |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Science
Zip code
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL
+81-75-571-1111
Homepage URL
nakano-h@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana University
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
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 | 06 | Month | 30 | 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
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | 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
| 2018 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037864
