UMIN-CTR Clinical Trial

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
Email	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
Email	zipputanaka@gmail.com

Sponsor
Institute	Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025688