UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032107