UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013729 |
|---|---|
| Receipt number | R000016029 |
| Scientific Title | Comparison of the efficacy of swallowing rehabilitation between that with interferential current stimulation and that with VitalStim therapy |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2019/10/19 10:58:18 |
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Basic information
Public title
Comparison of the efficacy of swallowing rehabilitation between that with interferential current stimulation and that with VitalStim therapy
Acronym
Efficacy of interferential current stimulation and VitalStim therapy
Scientific Title
Comparison of the efficacy of swallowing rehabilitation between that with interferential current stimulation and that with VitalStim therapy
Scientific Title:Acronym
Efficacy of interferential current stimulation and VitalStim therapy
Region
| Japan |
Condition
Condition
patients with dysphagia
Classification by specialty
| Neurology | Geriatrics | Oto-rhino-laryngology |
| Oral surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficacy of swallowing rehabilitation for stable patients with dysphagia between that with interferential current stimulation and that with VitalStim therapy over that without additional therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Swallowing function assessment by videofluorography
Key secondary outcomes
Mann Assessment of Swallowing Ability (MASA), Simple two step swallowing provocation test, tongue pressure, Manual Muscle Testing (MMT) of quadriceps femoris
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
swallowing rehabilitation only
Interventions/Control_2
swallowing rehabilitation with interferential current stimulation
Interventions/Control_3
swallowing rehabilitation with VitalStim therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in recovery beds with dysphagia within three months after the onset of disease, who are treated with swallowing rehabilitation
Key exclusion criteria
1. Respiratory, chest wall, and mediastinal disturbances due to aspiration greater than grade 2 (Common Terminology Criteria for Adverse Events (CTCAE) v4.0)
2. Severe dementia (MMSE < 10)
3. Those who cannot report sensations associated with electrical stimulation
4. Those who are judged by a medical stuff in charge as inappropriate candidates
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Division of Physiome, Department of Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
yoku@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Division of Physiome, Department of Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
Homepage URL
kobayuu1@hyo-med.ac.jp
Sponsor or person
Institute
Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department
Personal name
Funding Source
Organization
J Craft Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
わかくさ竜間リハビリテーション病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | 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
| 2014 | Year | 04 | Month | 16 | 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=R000016029
| 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 |
