UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007200 |
|---|---|
| Receipt number | R000008469 |
| Scientific Title | Evaluation of effects of interferential current stimulation on dysphagia |
| Date of disclosure of the study information | 2012/02/02 |
| Last modified on | 2015/08/02 13:08:12 |
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Basic information
Public title
Evaluation of effects of interferential current stimulation on dysphagia
Acronym
Effects of interferential current stimulation on dysphagia
Scientific Title
Evaluation of effects of interferential current stimulation on dysphagia
Scientific Title:Acronym
Effects of interferential current stimulation on dysphagia
Region
| Japan |
Condition
Condition
Patients with dysphagia
Classification by specialty
| Medicine in general | Pneumology | Neurology |
| Geriatrics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of interferential current stimulation on dysphagia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Timing analyses, distance measure of hyoid elevation, and residue score based on simple two-step swallowing provocation test and videofluorographic study
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interferential current stimulation
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cerebrovascular disease or Parkinson's disease, clinical severity grading of dysphasia 3-6, stable state, and those who are able to eat foods upon instruction.
Key exclusion criteria
Patients with cognitive disorder (MMSE < 21), patients with ataxia or dyskinesia, two or more episodes of aspiration pneumonia or asphyxia within 6 month.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Department of Physiology,
Hyogo College of Medicine
Division name
Division of Physiome
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
Department of Physiology,
Division name
Division of Physiome
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
Homepage URL
yoku@hyo-med.ac.jp
Sponsor or person
Institute
Department of Physiology,
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
高砂市民病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.12970/2311-1917.2015.03.01.1
Number of participants that the trial has enrolled
Results
Abstract: We have previously shown that surface interferential current (IFC) stimulation at the sensory threshold significantly increases the number of swallows.In the present study, we evaluated the effects of IFC stimulation at the sensory threshold on the swallowing reflex of dysphagic patients (7 male and 5 female, Age, 75.8 +- 5.3 years) by videofluoroscopic (VFS) measurements. Each subject underwent three series of VFS examination, before, during, and after the IFC stimulation. We tested three food types, juice, jelly, and biscuits, however, only juice consistency resulted in significant changes in temporal measurements of VFS parameters before, during and after IFC stimulation. For juice consistency, IFC stimulation shortened the pharyngeal response duration (the duration from the hyoid bone beginning maximum elevation to its return to the resting position, before IFC: 1.37 +- 0.31(SD) s vs. during IFC: 1.17 +- 0.29 s, p<0.001) without changing the amount of anterior and vertical displacements of the hyoid bone. The duration from the onset of elevation of the soft palate to return to the resting position was also significantly shortened by the IFC stimulation (before IFC: 0.72 +- 0.16 s vs. during IFC: 0.64 +- 0.19 s, p=0.035), suggesting that pharyngeal motor activation sequence as a whole was shortened by the IFC stimulation. No painful and/or uncomfortable sensations were reported. We conclude that surface interferential current stimulation has a potential to be an alternative mode of therapeutic electrical stimulation for dysphagic patients.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 02 | Day |
Last modified on
| 2015 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008469
| 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 |
