UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010917 |
|---|---|
| Receipt number | 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 21:15:03 |
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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
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
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012776
