UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027891 |
|---|---|
| Receipt number | R000031439 |
| Scientific Title | Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity. |
| Date of disclosure of the study information | 2017/06/24 |
| Last modified on | 2022/06/27 16:54:06 |
* 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
Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Acronym
Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Scientific Title
Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Scientific Title:Acronym
Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure the electric potential in the oral cavity. We estimate the tongue motion from the measured potentials and develop a visual feedback system using the estimation results. We evaluate the effect of the system on tongue exercise to adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the visual feedback effect of the estimation results of the tongue exercise using Fitts' law.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1.Feedback training is participated.
2.The training period is less than one hour.
3.After the training, participants are evaluated the tongue movement performance.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People
1) 20 years-old or older and under 65 years-old.
2) does not have the ingestion/swallow difficulty.
Key exclusion criteria
Peaple
1) undergoing dental treatment.
2) with an injury on the oral cavity or tongue.
3) with metal allergy
4) with alcohol Intolerance
5) after alcohol consumption
6) uses cardiac pacemaker.
8) with infectious disease or Malignant tumors.
9) with bleeding diathesis
10) with 37 Celsius degree or higher body temperature
11) with 180 mm/Hg or higher of the systolic pressure and 90 mm/Hg or lower of the lowest blood pressure.
12) whose heart rate is 100 beats or more or less than 40 beats.
13) yanger than 20 years-old and older than 65 years-old.
14) who judged to inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Nakatani |
Organization
Tottori University
Division name
Graduate School of Engineering
Zip code
6808552
Address
101, 4 Cho-me, Koyama-cho Minami, Tottori 680-8550 Japan
TEL
0857-31-5835
snakatani@mech.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Nakatani |
Organization
Tottori University
Division name
Graduate School of Engineering
Zip code
6808552
Address
101, 4 Cho-me, Koyama-cho Minami, Tottori 680-8550 Japan
TEL
0857-31-5835
Homepage URL
snakatani@mech.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Hyogo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University
Address
4-101, Koyama-cho Minami, Tottori-shi, Tottori 680-8552 Japan
Tel
0857315835
snakatani@tottori-u.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
| 2017 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
