UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013104 |
|---|---|
| Receipt number | R000015287 |
| Scientific Title | Developemt of new rehabilitation method using combination of the brain and peripheral nerve dual electrical stimulation |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2019/08/13 16:49:38 |
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Basic information
Public title
Developemt of new rehabilitation method using combination of the brain and peripheral nerve dual electrical stimulation
Acronym
Dual stimulation of the brain and peripheral nerve for the new rehabilitation method
Scientific Title
Developemt of new rehabilitation method using combination of the brain and peripheral nerve dual electrical stimulation
Scientific Title:Acronym
Dual stimulation of the brain and peripheral nerve for the new rehabilitation method
Region
| Japan |
Condition
Condition
healthy adults
Cervical spondylotic myelopathy patients
Stroke patients
Classification by specialty
| Neurology | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To development of new rehabilitation methods using dual stimulation of brain and peripheral nerve stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MEP
skilled motor function
muscle strength
sensory assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dual stimulation of brain and peripheral nerve stimulation.
Interventions/Control_2
sham stimulation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults: No orthopaedic and neulorogical disorders
CSM patients: Clinical signs by chronic cervical cord compression
Stroke patients: Hemiplegia caused by cerebral infarction
Key exclusion criteria
have a communication problem, or acute progression of symptoms
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | masafumi |
| Middle name | |
| Last name | kubota |
Organization
University of Fukui Hospital
Division name
Division of Physical Therapy and Rehabilitation Medicine
Zip code
9101193
Address
Matsuoka-Shimoaizuki 23, Eiheiji, Fukui, Japan
TEL
0776-61-3111
kubotama@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | masafumi |
| Middle name | |
| Last name | kubota |
Organization
University of Fukui Hospital
Division name
Division of Physical Therapy and Rehabilitation Medicine
Zip code
9101193
Address
Matsuoka-Shimoaizuki 23, Eiheiji, Fukui, Japan
TEL
0776-61-3111
Homepage URL
kubotama@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
fukui university
Address
eiheiji matsuoka23-3, yosida, fukui, JAPAN
Tel
0776-61-3111
kubotama@u-fukui.ac.jp
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
| 2014 | Year | 02 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | 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
| 2014 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015287
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
