UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021912 |
|---|---|
| Receipt number | R000025192 |
| Scientific Title | Factors related to the outcome of Integrated Volitional controlled Electrical Stimulation (IVES) therapy for chronic stroke |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/10/19 13:48:32 |
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Basic information
Public title
Factors related to the outcome of Integrated Volitional controlled Electrical Stimulation (IVES) therapy for chronic stroke
Acronym
IVES therapy for chronic stroke
Scientific Title
Factors related to the outcome of Integrated Volitional controlled Electrical Stimulation (IVES) therapy for chronic stroke
Scientific Title:Acronym
IVES therapy for chronic stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the therapeutic approach for severe upper limb paresis in chronic stroke patients, we explore the factors related to the outcome of IVES therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer asseesment for upper extremities, and WMFT testings at just after and 3 month after the end of intervention.
Key secondary outcomes
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
To encourage the use of the paretic limbs during daily life and daily occupational therapy with IVES for 21 days.
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
| 14 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with hemiparesis dues to stroke
2. at least 6 month after the stroke
3. Able to understand and consent the objective and method of the study
4. SIAS knee-mouth test >= 2
5. SIAS finger test < 3
6. Passive range of finger extention > 0 degree
7. Muscle contraction is detectable from the extensor digitrum communis or extensor pollicis longus
8. Independent ambulatory ability with/without walking aids
9. Independent ADL ability with/without functional aids
Key exclusion criteria
Contraindication for physical therapy and/or electorical stimulation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Meigen |
| Middle name | |
| Last name | Liu |
Organization
Keio Univ sch. med
Division name
Dept. Rehabilitation Med
Zip code
1608582
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3833
meigenliukeio@mac.com
Public contact
Name of contact person
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
Keio Univ sch. med
Division name
Dept. Rehabilitation Med
Zip code
160-8582
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3833
Homepage URL
s-tashiro@umin.net
Sponsor or person
Institute
Keio Univ sch. med
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports. Science and Technology
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
Keio University School of Medicine
Address
Shinano-machi 35, Shinjuku-city
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2015-466
Org. issuing International ID_1
Keio univ sch med
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | 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
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025192
| 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 |
