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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033703
Receipt No. R000037923
Official scientific title of the study The effects of sound leg shoe-lift on hemiplegic gait - before-after study-
Date of disclosure of the study information 2018/08/09
Last modified on 2018/08/09

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Basic information
Official scientific title of the study The effects of sound leg shoe-lift on hemiplegic gait - before-after study-
Title of the study (Brief title) Effects of sound leg shoe-lift on hemiplegic gait
Region
Japan

Condition
Condition Hemiplegia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the effect of sound leg shoe-lift on hemiplegic gait using objective indicators
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of variation of toe clearance (foot-to-floor distance) for swing on the paralyzed side between sound leg shoe-lift conditions
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 Walking on a level ground with four types of sound leg shoe-lift conditions using three dimensional motion analysis and surface electromyography
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients aged 20 years or older and under 80 years old who gave informed consent
2.Hemiplegic Patients who use orthosis and sound leg shoe-lift in daily life
3.Hemiplegic Patients who do not require assistance to walk
4.Hemiplegic Patients who can walk on level ground without using walking aid and sound leg shoe-lift
Key exclusion criteria 1.Hemiplegic Patients with severe higher brain dysfunction
2.Hemiplegic Patients with complications that influence walk such as severe orthopedic diseases

Target sample size 15

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 470-1192, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person Hikaru Kondo
Organization Fujita Health University Hospital
Division name Department of Rehabilitation
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL 0562-93-2155
Homepage URL
Email khikaru@fujita-hu.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 08 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 09 Day
Anticipated trial start date
2018 Year 08 Month 09 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 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037923

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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