UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020399 |
|---|---|
| Receipt number | R000023535 |
| Scientific Title | Evaluation of voluntary tongue lift movement |
| Date of disclosure of the study information | 2015/12/29 |
| Last modified on | 2015/12/29 20:18:53 |
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Basic information
Public title
Evaluation of voluntary tongue lift movement
Acronym
Evaluation of voluntary tongue lift movement
Scientific Title
Evaluation of voluntary tongue lift movement
Scientific Title:Acronym
Evaluation of voluntary tongue lift movement
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have developed a new modality that enabled to detect and visualize the posterior tongue lift movement which it was difficult to observe and evaluate in usual method.
The purpose of this study was to elucidate the tongue lifting function, especially in the posterior part to the tongue by the device we developed.
Basic objectives2
Others
Basic objectives -Others
Dynamic property of the posterior part of tongue
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Following 5 parameters calculated from the data about trajectories of posterior tongue surface;
(1) maximum upward velocity (MUV)(mm/s)
(2) range of tongue lift (TLift)(mm)
(3) distance from palate to uppermost point of tongue (P-T)(mm)
(4) duration from the beginning of the movement to the maximum attainment point (D)(s)
(5) maximum downward velocity (MDV)(mm/s)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
1. Basic measurement of movement of posterior tongue
Subjects were seated in an upright position and instructed the following tasks;
1) effortful swallowing
2) phonation
2. Measurement of movement of posterior tongue in various posture
Subjects were seated in the following 4 posture. In each posture, movement of posterior tongue was measured with a neck rotated 15 degrees to the right, 0 degree and 15 degrees to the left.
1) upright position
2) 30 degrees face up position
3) 60 degrees face up position
4) 120 degrees face up position
Ten repetitive trials were conducted above all conditions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy Adult (more than 20 years old)
2) The person who did not have subjective difficulties in swallowing or food intake
3) The person who was diagnosed as there being no doubt of aspiration by swallowing test.
Key exclusion criteria
The person who was suspected to have aspiration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
minagi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Oki |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
Homepage URL
kazu_z@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Twenty-three healthy volunteers (9 men and 14 women; mean age, 27.6 years) participated in this study. A new device was developed that could evaluate the up-down movement of the posterior part of the tongue in a non-invasive manner.
The experimental tasks were as follows: (i) /a/ pronunciation for 1 s followed by /ka/ pronunciation (a-ka task), (ii) /a/ pronunciation for 1 s followed by /ga/ pronunciation (a-ga task) and (iii) /a/ pronunciation for 1 s followed by a voluntary push-up movement of the posterior part of the tongue (a-lift task).
Maximum upward velocity in the a-ga task was larger than that in the a-ka task (P < 0.05). The a-lift task showed the highest tongue lift range among the three tasks, and the a-ga task showed a higher range than that of the a-ka task (P < 0.05).
This study revealed that precise quantification of the motility of the posterior part of the tongue, which would be useful in rehabilitation of articulation and/or swallowing, could be achieved using this new device in a non-invasive manner.
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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 29 | Day |
Last modified on
| 2015 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023535
