UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037357 |
|---|---|
| Receipt number | R000042592 |
| Scientific Title | Effects of Interferential current sensory stimulation on acute stroke Dysphagia a double blind randomized controlled trial |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2019/07/12 19:44:44 |
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Basic information
Public title
Effects of Interferential current sensory stimulation on acute stroke Dysphagia a double blind randomized controlled trial
Acronym
Effects of Interferential current sensory stimulation on acute stroke Dysphagia a double blind randomized controlled trial
Scientific Title
Effects of Interferential current sensory stimulation on acute stroke Dysphagia a double blind randomized controlled trial
Scientific Title:Acronym
Effects of Interferential current sensory stimulation on acute stroke Dysphagia a double blind randomized controlled trial
Region
| Japan |
Condition
Condition
acute stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Interferential current sensory stimulation on acute stroke Dysphagia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough test score
Key secondary outcomes
mMASA score,RSST score,Fois score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interferential current sensory stimulation for 20 minutes at the same time as rehabilitation of dysphagia for 10days for Interventions.
Interventions/Control_2
Sham for 20 minutes at the same time as rehabilitation of dysphagia for 10days for Contlol.
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)Not Dysphagia before stroke
2)Within one month of onset
3)Twenty years of age or older
4)A patient who has agreed to the study
Key exclusion criteria
1)Pregnant women
2)Patients using pacemakers or ICDs
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ishihara |
Organization
Tokai University Hospital
Division name
Rehabilitation Services Department
Zip code
259-1193
Address
143 Shimokasuya Isehara shi KANAGAWA
TEL
0463-93-1121
t-ishihara@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ishihara |
Organization
Tokai University Hospital
Division name
Rehabilitation Services Department
Zip code
259-1193
Address
143 Shimokasuya Isehara shi KANAGAWA
TEL
0463-93-1121
Homepage URL
t-ishihara@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai University 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
Tokai University Hospital
Address
143 Shimokasuya Isehara shi KANAGAWA
Tel
0463-93-1121
t-ishihara@tokai.ac.jp
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
| 2019 | Year | 07 | Month | 12 | 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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042592
