UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028119 |
|---|---|
| Receipt number | R000032107 |
| Scientific Title | Investigation of feedback effects using waveform displaying software of tongue pressure. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2022/07/11 12:54:53 |
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Basic information
Public title
Investigation of feedback effects using waveform displaying software of tongue pressure.
Acronym
Investigation of feedback effects of tongue pressure.
Scientific Title
Investigation of feedback effects using waveform displaying software of tongue pressure.
Scientific Title:Acronym
Investigation of feedback effects of tongue pressure.
Region
| Japan |
Condition
Condition
Dysphagia, Dysarthria
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate visual feedback effects on tongue pressure during training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Trial 1 Comparison between feedback condition and non-feedback condition
Maximum tongue pressure, Modified tongue pressure, Average peak pressure, Modified average peak pressure, tongue pressure slope, Modified tongue pressure slope and Time to peak
Trial 2 Comparison between waveform feedback condition and value feedback condition
Average tongue pressure in endurance task, coefficient of variation, Revised average tongue pressure and Revised coefficient of variation.
In accuracy training, average tongue pressure
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
A: Training Group: Three conditions will be perform; with waveform feedback, with numerical value feedback, and without feedback of tongue pressure.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with
1) decreasing tongue pressure compared with average in participant's age, 2) Dysarthria or Dysphagia.
Key exclusion criteria
Participants can't understand the instruction
about oral movement because of dementia, higher brain function disorder and aphasia.
Participants could aspirate their saliva during tongue elevation because of severe dysphagia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture 663-8501, Japan.
TEL
0798-45-6345
domen@neuro-reha.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Nanto |
Organization
Hyogo College of Medicine College Hospital
Division name
Department of Rehabilitation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture 663-8501, Japan.
TEL
0798-45-6345
Homepage URL
s0315028@hotmail.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2022 | 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=R000032107
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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