UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022295 |
|---|---|
| Receipt number | R000025688 |
| Scientific Title | Effects of insoles is given to the mechanical stress on the knee joint during walking and running |
| Date of disclosure of the study information | 2016/05/13 |
| Last modified on | 2019/11/17 06:11:37 |
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Basic information
Public title
Effects of insoles is given to the mechanical stress on the knee joint during walking and running
Acronym
Effects of insoles is given to the mechanical stress on the knee joint during walking and running
Scientific Title
Effects of insoles is given to the mechanical stress on the knee joint during walking and running
Scientific Title:Acronym
Effects of insoles is given to the mechanical stress on the knee joint during walking and running
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Sports injuries
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
That the insoles to verify or give what kinematics, dynamics changes in the lower limb joint during walking and running
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower extremity joint moments
Lower limb joint angle
Knee joint outside acceleration
Leg strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
insoles
Intervention period is 1 hour
Intervention number of times once
Interventions/Control_2
shoes
Intervention period is 1 hour
Intervention number of times once
Interventions/Control_3
lateral wedged insoles
Intervention period is 1 hour
Intervention number of times once
Interventions/Control_4
medial wedged insoles
Intervention period is 1 hour
Intervention number of times once
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person can be 10m walking
Key exclusion criteria
A person who has a musculoskeletal disease and neurological disease in history
Those who can not understand the description of the present study
And those who can not be obtained the consent
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kazuhiro |
Organization
Matsumoto Hospital,Hyogo,Japan
Division name
Department of Rehabilitation
Zip code
675-0039
Address
KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan
TEL
079-424-0333
zipputanaka@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kazuhiro |
Organization
Matsumoto Hospital,Hyogo,Japan
Division name
Department of Rehabilitation
Zip code
675-0039
Address
KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan
TEL
079-424-0333
Homepage URL
zipputanaka@gmail.com
Sponsor or person
Institute
Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan
Name of secondary funder(s)
Takahiko Fukumoto
IRB Contact (For public release)
Organization
Matsumoto Hospital
Address
KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan
Tel
079-424-0333
zipputanaka@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
| 2016 | Year | 05 | Month | 13 | 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
12
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
| 2016 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025688
