UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007200
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email yoku@hyo-med.ac.jp

Public contact
1st 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
Email yoku@hyo-med.ac.jp

Sponsor
Institute Department of Physiology,
Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.