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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031989
Receipt No. R000036032
Scientific Title Investigation of Factors Affecting Knee Extension Limit
Date of disclosure of the study information 2018/04/02
Last modified on 2019/12/02

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Basic information
Public title Investigation of Factors Affecting Knee Extension Limit
Acronym Investigation of Factors Affecting Knee Extension Limit
Scientific Title Investigation of Factors Affecting Knee Extension Limit
Scientific Title:Acronym Investigation of Factors Affecting Knee Extension Limit
Region
Japan

Condition
Condition nothing special
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the influence on the knee joint function itself due to restriction of extension of the knee joint and the influence on the trunk, hip joint and ankle joint, to examine the necessity of acquiring normal range of motion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gait
Key secondary outcomes muscle hardness,Muscular strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Period of intervention:after approval - March 31, 2022
Interventions/Control_2 Number of interventions:once
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria 1:Persons whose age is 20 years or older at the time of consent acquisition
2:Persons who do not have pain in the body
3:Those who have not restricted each joint range
4:After receiving sufficient explanation for participation in this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria 1:Persons who have pain in the body
2:Persons who have experienced trauma or disorder in any of the bodies
3:Other subjects who judged that the person responsible for implementation was inappropriate as the research subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Etsuo
Middle name
Last name Chosa
Organization Miyazaki University Medical School Hospital
Division name Department of Rehabilitation
Zip code 889-1692
Address 5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
TEL 0985-85-9849
Email igakubu_kenkyu@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name AKio
Middle name
Last name Imamura
Organization Miyazaki University Medical School Hospital
Division name Department of Rehabilitation
Zip code 889-1692
Address 5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
TEL 0985-85-9849
Homepage URL
Email akio_imamura@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University Medical School Hospital
Institute
Department

Funding Source
Organization Miyazaki University Medical School Hospital
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 Miyazaki University Medical School Hospital
Address 5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
Tel 0985-85-9849
Email igakubu_kenkyu@med.miyazaki-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 02 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 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 03 Month 29 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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