UMIN-CTR Clinical Trial

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

Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027891
Receipt No. 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

* 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
Email 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
Email snakatani@mech.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

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
Email 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
URL(English) 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


Contact us.