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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019583
Receipt No. R000022638
Scientific Title The short-term effect of ankle foot orthosis FAJO which considered the function and the appearance : The gait analysis of stroke patients
Date of disclosure of the study information 2015/12/01
Last modified on 2015/10/31

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Basic information
Public title The short-term effect of ankle foot orthosis FAJO which considered the function and the appearance : The gait analysis of stroke patients
Acronym The short-term effect of use of FAJO
Scientific Title The short-term effect of ankle foot orthosis FAJO which considered the function and the appearance : The gait analysis of stroke patients
Scientific Title:Acronym The short-term effect of use of FAJO
Region
Japan

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

Objectives
Narrative objectives1 To show the kinetic or kinematic change of the gait of stroke patients before and after short term AFO use.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait analysis
Each analysis parameter
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 3 weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients in living period.
The patients who use AFO daily.
Key exclusion criteria Severe limitation of ROM.
Cognitive problem to prevent understand of instruction.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Murayama
Organization International university of health and welfare
Division name A Master's course. Preservation of health medical treatment science specialty.
Zip code
Address 1-3-3, Minamiaoyama, Minato-ku, Tokyo
TEL 03-6406-8621
Email tokyo.s.c@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Murayama
Organization International university of health and welfare
Division name A Master's course. Preservation of health medical treatment science specialty.
Zip code
Address 1-3-3, Minamiaoyama, Minato-ku, Tokyo
TEL 03-6406-8621
Homepage URL
Email tokyo.s.c@iuhw.ac.jp

Sponsor
Institute International university of health and welfare
Institute
Department

Funding Source
Organization None
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 船橋市立リハビリテーション病院(千葉県)
Funabashi Municipal Rehabilitation Hospital(Chiba-ken)

Other administrative information
Date of disclosure of the study information
2015 Year 12 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 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
2015 Year 10 Month 31 Day
Last modified on
2015 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022638

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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