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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028946
Receipt No. R000033117
Scientific Title The analysis of gait strategy in hemiparetic gait
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/31

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Basic information
Public title The analysis of gait strategy in hemiparetic gait
Acronym The gait strategy in hemiparetic gait
Scientific Title The analysis of gait strategy in hemiparetic gait
Scientific Title:Acronym The gait strategy in hemiparetic gait
Region
Japan

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

Objectives
Narrative objectives1 To investigate the gait strategy of stroke patients and its change by using AFOs during the swing phase and the stance phase of the gait cycles.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Toe displacement and spatiotemporal parameters
Key secondary outcomes Joint angle changes and abnormal gait indices

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The presence of hemiparesis
The use of ankle foot orthosis
The ability to walk without handrail nor orthosis
Key exclusion criteria The presence of muscular disease
The presence of orthopaedic disease
The presence of neurological disease other than stroke
Target sample size 20

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

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Mukaino
Organization Fujita Health University, School of Medicine
Division name Department of Rehabilitation Medicine I
Zip code
Address Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi
TEL 0562-93-2167
Homepage URL
Email mmukaino@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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, the effects regarding the use of AFO was compared retrospectively.

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033117

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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