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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039220
Receipt No. R000044492
Scientific Title Exploratory study on the effectiveness of the knee orthosis that prevent the inappropriate knee bending during the stance phase
Date of disclosure of the study information 2020/01/21
Last modified on 2021/01/21

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Basic information
Public title Exploratory study on the effectiveness of the knee orthosis that prevent the inappropriate knee bending during the stance phase
Acronym The effectiveness of the knee orthosis that prevent the inappropriate knee bending during the stance phase
Scientific Title Exploratory study on the effectiveness of the knee orthosis that prevent the inappropriate knee bending during the stance phase
Scientific Title:Acronym The effectiveness of the knee orthosis that prevent the inappropriate knee bending during the stance phase
Region
Japan

Condition
Condition Patients with the inappropriate knee bending gait pattern during the stance phase
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness to improvement in the walking ability when the patients with the inappropriate knee bending gait pattern use the knee orthosis that prevent the inappropriate knee bending during the stance phase
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The index using 3D gait analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The gait exercise using the knee orthosis that prevent the knee bending during the stance phase
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with the inappropriate knee bending gait pattern
Key exclusion criteria Unstable vital sign
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation medicine I, School of medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Hirano
Organization Fujita Health University
Division name Department of Rehabilitation medicine I, School of medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email rehabmed@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Toyota motor corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Research IRB, Center for research promotion and support, Fujita Health University
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel 0562-93-2865
Email f-irb@fujita-hu.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
2020 Year 01 Month 21 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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 02 Day
Date of IRB
2020 Year 06 Month 15 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 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
2020 Year 01 Month 21 Day
Last modified on
2021 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044492

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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