UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013298 |
|---|---|
| Receipt number | R000015497 |
| Scientific Title | Effects of shoes and insoles has on the mechanical stress of the knee joint |
| Date of disclosure of the study information | 2014/02/28 |
| Last modified on | 2016/03/03 22:42:41 |
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Basic information
Public title
Effects of shoes and insoles has on the mechanical stress of the knee joint
Acronym
Effects of shoes and insoles has on the mechanical stress of the knee joint
Scientific Title
Effects of shoes and insoles has on the mechanical stress of the knee joint
Scientific Title:Acronym
Effects of shoes and insoles has on the mechanical stress of the knee joint
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect insoles and shoes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower extremity joint moments
Lower limb EMG
Foot pressure center trajectory
Knee joint outside acceleration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
barefoot
Interventions/Control_2
lateral wedged insoles
Interventions/Control_3
medial wedged insoles
Interventions/Control_4
insoles of the hindfoot
Interventions/Control_5
insoles of the forefoot
Interventions/Control_6
shoes adapted size
Interventions/Control_7
shoes size incompatibility
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person walking 10m is possible
Key exclusion criteria
A person who has a neurological disease and musculoskeletal disease marked in osteoarthritis of the knee other than
Those who can not consent and who can not understand the description of the present study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Tanaka |
Organization
Kio University Graduate School
Division name
Health Sciences
Zip code
Address
Nara Katsuragi gun Koryo-cho 4-2-2 Umaminaka
TEL
0745-54-1602
zipputanaka@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Tanaka |
Organization
Kio University Graduate School
Division name
Health Sciences
Zip code
Address
Nara Katsuragi gun Koryo-cho 4-2-2 Umaminaka
TEL
0745-54-1602
Homepage URL
zipputanaka@gmail.com
Sponsor or person
Institute
Kio University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kio University Graduate School of Health Sciences
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
| 2014 | Year | 02 | Month | 28 | 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 | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 27 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015497
| Research Plan | |
|---|---|
| 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 |
