UMIN-CTR Clinical Trial

Basic information
Public title	Research for load on the knee during various motions by motion analysis using optical makers
Acronym	Motion analysis for load on the knee
Scientific Title	Research for load on the knee during various motions by motion analysis using optical makers
Scientific Title:Acronym	Motion analysis for load on the knee
Region	Japan

Condition
Condition	anterior cruciate ligament
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarification for mechanism of anterior cruciate ligament injury
Basic objectives2	Others
Basic objectives -Others	Study for prevention of anterior cruciate ligament
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Load to the knee joint and muscle powers in variour motions
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	15 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult volunteer
Key exclusion criteria	Past history of low extrimity injury
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Tatsuo Middle name Last name Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Zip code	3598513
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Email	tkobayas@ndmc.ac.jp

Public contact
Name of contact person	1st name Tatsuo Middle name Last name Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Zip code	3598513
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Homepage URL
Email	tkobayas@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
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	National Defense Medical College
Address	3-2, Namiki, Tokorozawa, Saitama
Tel	0429951511
Email	tkobayas@ndmc.ac.jp

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	防衛医科大学校（埼玉）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	2016 Year 02 Month 26 Day
Date of IRB	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 02 Month 26 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate when the ACL is tensioned and how much load is imposed in walking, jogging, squatting and jumping action by motion analysis using optic markers.

Management information
Registered date	2016 Year 02 Month 26 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022433