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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034810
Receipt No. R000039698
Official scientific title of the study Survey and research on shoes for paralytic diseases
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/07

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Basic information
Official scientific title of the study Survey and research on shoes for paralytic diseases
Title of the study (Brief title) Research of shoes of paralytic disease
Region
Japan

Condition
Condition Cerebral vascular disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to clarify the needs and problems of
shoes by users of lower extremity orthosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Shoe worries of the user of users of lower extremity orthosis
Key secondary outcomes Shoe size, type, needs, fit,design,Foot length,foot width

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 We wear shoes under development for one week and conduct questionnaire survey including feeling of fit
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 using lower extremity orthosis that can walk independently
Key exclusion criteria Those who are difficult to respond to questionnaires due to disturbance of consciousness and cognitive function, patients who decline stability of walking by changing shoes.Patient with history of fall
Target sample size 5

Research contact person
Name of lead principal investigator Eiichi Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, school of Medicine
Address 1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL 0652-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person Asuka Hirano
Organization Fujita Health University Hospital
Division name Department of Rehabilitation
Address 1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL 0652-93-2155
Homepage URL
Email a-hirano@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 11 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 21 Day
Anticipated trial start date
2018 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039698

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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