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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028119
Receipt No. 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 2019/02/27

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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
Email 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
Email s0315028@hotmail.co.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 07 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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