UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041861 |
|---|---|
| Receipt number | R000047788 |
| Scientific Title | Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES). |
| Date of disclosure of the study information | 2020/09/22 |
| Last modified on | 2020/09/22 19:44:33 |
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Basic information
Public title
Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Acronym
Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Scientific Title
Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Scientific Title:Acronym
Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intervene using IVES from acute stage to examine the therapeutic effect of finger function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Key secondary outcomes
Brunnstrom rerovery stage
Modified ashworth scale
Motor Activity Log
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
IVES
Interventions/Control_2
Usual rehabilitation program alone
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
1)the patient with motor disability in upper extremity,2)Those who passed within 21days since onset, 3) It is possible to detect the electromyogram of finger extension using the integrated volitional control electrical stimulation device.
Key exclusion criteria
1) severe limited range of motion in wrist,2) severe sensory disturbance , 3) severe higher brain dysfunction, 4) patients with the contraindication of electrical stimulation therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya Tokushukai General Hospital
Division name
Rehabilitation
Zip code
487-0016
Address
2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
TEL
0568-51-8711
kmkmjpn@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya Tokushukai General Hospital
Division name
Rehabilitation
Zip code
487-0016
Address
2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
TEL
0568-51-8711
Homepage URL
kmkmjpn@gmail.com
Sponsor or person
Institute
Nagoya Tokushukai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya Tokushukai General 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
Nagoya Tokushukai General Hospital
Address
2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
Tel
0568-51-8711
kmkmjpn@gmail.com
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
| 2020 | Year | 09 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047788
| Research Plan | |
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| 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 |
