UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of Ankle Foot Orthosis by applying Magnetic Rheological fluid brake
Title of the study (Brief title)	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	Sosuke Seki
Organization	Kawasaki Medical School
Division name	Rehabilitation Medicine
Address	577 Matsushima,Kurashiki-city,Okayama Prefecture,701-0192 Japan
TEL
Email

Public contact
Name of contact person
Organization	Kawaseki Medical School
Division name	Rehabilitation Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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