UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013104
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kubotama@u-fukui.ac.jp

Sponsor
Institute University of Fukui Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.