UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001971 |
|---|---|
| Receipt number | R000002404 |
| Scientific Title | Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke. |
| Date of disclosure of the study information | 2009/05/18 |
| Last modified on | 2019/03/06 09:54:56 |
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Basic information
Public title
Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Acronym
Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Scientific Title
Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Scientific Title:Acronym
Developement of Integrated Volitional Control Electrical Stimulator(IVES) and its therapeutic effects in patients with stroke.
Region
| Japan |
Condition
Condition
Healthy subjests, Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developement of Integrated Volitional control Electrical Stimulator (IVES) and its therapeutic effects in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroke Impairment Assessment Set(SIAS),Fugl-Meyer Assessment, Action Research Arm Test
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
Integrated Volitional control Electrical Stimulator(IVES) and Prosthesis
Interventions/Control_2
Only Prosthesis
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
Key inclusion criteria
First Attack of Stroke, Affected finger paresis is lower than 2 classified by Stroke Impairment Assessment Set.
Key exclusion criteria
Episode of epilepsy, Cogniive Deficits difficult to understand the study, Metalic something in body
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Shindo |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
TEL
Homepage URL
kshindo@tokyo-reha.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Tokyo Metropolitan Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Rehabilitation Hospital
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
| 2009 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/1545968311408917?url_ver=Z39.88-2003&rfr_id=ori%3Arid%
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
Completed
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002404
