UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028189 |
|---|---|
| Receipt number | R000032268 |
| Scientific Title | Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia. |
| Date of disclosure of the study information | 2017/07/12 |
| Last modified on | 2017/07/11 21:24:23 |
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Basic information
Public title
Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Acronym
Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Scientific Title
Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Scientific Title:Acronym
Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Region
| Japan |
Condition
Condition
Patients with dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify of effectiveness using neuromuscular electrical stimulation for patients with dysphagia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Videofluorography
Key secondary outcomes
Videoendoscopy
High-resolution manometry
Surface electromyogram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
swallowing rehabilitation only
Interventions/Control_2
Neuromuscular electrical stimulation
Duration of a treatment session: 30 minutes
Duration of the treatment: 5days/week for 2 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with pharyngeal dysphagia.
Key exclusion criteria
1) Severe higher cortical dysfunction
2) Dementia
3) Neuromuscular diseases
4) Patients with tracheotomy
5) Patients with a pacemaker
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maya Nakahira |
Organization
Kochi Medical School University
Division name
Rehabilitation Center
Zip code
Address
Kohasu, Oko-cho, Nankoku City,Kochi, 783-8505 JAPAN
TEL
088-880-2490
jm-nakahira-m@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maya Nakahira |
Organization
Kochi Medical School University
Division name
Rehabilitation Center
Zip code
Address
Kohasu, Oko-cho, Nankoku City,Kochi, 783-8505 JAPAN
TEL
088-880-2490
Homepage URL
jm-nakahira-m@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School University
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032268
