UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030801 |
|---|---|
| Receipt number | R000035131 |
| Scientific Title | A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke |
| Date of disclosure of the study information | 2018/01/14 |
| Last modified on | 2018/01/14 15:10:37 |
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Basic information
Public title
A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Acronym
A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Scientific Title
A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Scientific Title:Acronym
A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of IVES for the upper limb function training of a chronic stroke unilateral upper limb paralysis patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MFT(Manual function Test) after one month of upper limb function training
Key secondary outcomes
MAS(Modified Ashworth Scale)
ADL(Activities of Daily Living)
Brunnstrom Stage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The upper limb function training using IVES
60 minutes a day
Three times a week
For four weeks
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Over six months since the onset of the stroke
Unilateral upper limb paralysis (hemiplegia or upper limb paralysis)
Walking function above functional Ambulation Category 2
Possible to understand the explanation of the research and the direction of the movement
Key exclusion criteria
Who may not be able to follow the instructions of therapist or doctor
Who has the possibility that exercise load cause physical activity to deteriorate
Who has tha possibility that physical condition interfere with the safe practice
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoko Asami |
Organization
Saga University Hospital
Division name
Department of rehabilitation
Zip code
Address
5-1-1, Nabeshima, Saga-shi, Saga, 849-8501, Japan
TEL
0952-31-6511
asamit@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Murata |
Organization
Saga University Hospital
Division name
Department of rehabilitation
Zip code
Address
5-1-1, Nabeshima, Saga-shi, Saga, 849-8501, Japan
TEL
0952-34-3285
Homepage URL
ss4512@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 14 | 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
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | 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
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2018 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035131
| 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 |
