UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044589 |
|---|---|
| Receipt number | R000050932 |
| Scientific Title | Effect of Electrical Stimulation on Hemiparetic Shoulder in Subacute Stroke: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/06/18 |
| Last modified on | 2021/06/18 14:00:28 |
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Basic information
Public title
Effect of Electrical Stimulation on Hemiparetic Shoulder in Subacute Stroke: A Randomized Controlled Trial
Acronym
Effect of Electrical Stimulation on Hemiparetic Shoulder in Subacute Stroke: A Randomized Controlled Trial
Scientific Title
Effect of Electrical Stimulation on Hemiparetic Shoulder in Subacute Stroke: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Electrical Stimulation on Hemiparetic Shoulder in Subacute Stroke: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of electrical stimulation on hemiparetic shoulder in patients with subacute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl Meyer Assessment - upper extremity
Action Research Arm Test
X-ray of the shoulder (Acromiohumeral distance)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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
EMG-triggered electrical stimulation + task practice
40 minutes /day, 5 days/week, 3 weeks
Interventions/Control_2
electrical stimulation
40 minutes /day, 5 days/week, 3 weeks
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were age 20 years and older, admission with a first-ever stroke, 4 to 12 weeks after the onset of stroke, self-care is independent in a wheelchair or walking, and moderate paralysis (FMA score 19 to 47 points)
Key exclusion criteria
The exclusion criteria included subarachnoid hemorrhage, bilateral lesions, cognitive impairment (MMSE score 23 points or less), and patients who are contraindicated for electrical stimulation.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6169
taisho8036@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
taisho8036@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5843-6169
taisho8036@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
東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050932
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
