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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010917
Receipt No. R000012776
Scientific Title Development of Ankle Foot Orthosis by applying Magnetic Rheological fluid brake
Date of disclosure of the study information 2013/07/01
Last modified on 2017/01/31

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Basic information
Public title Development of Ankle Foot Orthosis by applying Magnetic Rheological fluid brake
Acronym Development of MR AFO
Scientific Title Development of Ankle Foot Orthosis by applying Magnetic Rheological fluid brake
Scientific Title:Acronym Development of MR AFO
Region
Japan

Condition
Condition stroke , cerebral contusion , spinal cord injury , peripheral neuropathy
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We use MR AFO for lower limbs paralysis and evaluate for development of AFO which adapted to living environment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes walking speed, cadence, step
gait analysis(three-dimensional walk analysis, floor reaction force meter)
Questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 MR AFO
(Ankle Foot Orthosis by applying Magnetic Rheological fluid brake)
Interventions/Control_2 normal AFO
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 Lower limbs paralytic caused by stroke, cerebral contusion, spinal cord injury, peripheral neuropathy.
Key exclusion criteria The patient that an agreement is not provided
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sosuke Seki
Organization Kawasaki Medical School
Division name Rehabilitation Medicine
Zip code
Address 577 Matsushima,Kurashiki-city,Okayama Prefecture,701-0192 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawaseki Medical School
Division name Rehabilitation Medicine
Zip code
Address 577 Matsushima,Kurashiki-city,Okayama Prefecture,701-0192 Japan
TEL
Homepage URL
Email

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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
2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Terminated
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 10 Day
Last modified on
2017 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012776

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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