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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034356
Receipt No. R000039163
Scientific Title Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Date of disclosure of the study information 2018/10/02
Last modified on 2018/10/02

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Basic information
Public title Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Acronym Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Scientific Title Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Scientific Title:Acronym Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Geriatrics Oto-rhino-laryngology Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify that there is an additional effect of improvement of swallowing function compared with training of each alone by training the oropharyngeal and respiratory training for patients with mild to moderate swallowing disorders .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement degree of MASA (Mann Assessment of Swallowing Ability) score before and after training
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 4 weeks training of oral and oropharynx (tongue motion training and suprahyoid muscles training)
Interventions/Control_2 4 weeks breathing training (Huffing and Expiratory Muscle Strength Training)
Interventions/Control_3 4 weeks training of oral, oropharynx and breathing training (tongue motion training, suprahyoid muscles training, Huffing and Expiratory Muscle Strength Training)
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 Mild to moderate dysphagia (MASA score 139 to 177 points)
Key exclusion criteria (1) Dysphagia due to organic causes (ex.; Head and neck cancer, head and neck radiotherapy, after head and neck operation, esophagus cancer, postoperative esophagus cancer, after mediastinal radiation therapy, etc.)
(2) Dysphagia caused by diseases in which progression is expected on a monthly basis such as neuromuscular disease and terminal stage of cancer (Allowance when progression in yearly unit is expected)
(3) Acute onset Dysphagia (such as stroke) from acute to subacute (within 3 months after onset)
(4) swallowing disorder expected to be relieved by medication treatment (autoimmune myositis etc, drug treatment ineffective cases are acceptable)
(5) Drug-induced dysphagia (Those considered to require adjustment of medicines, allowance for invalid drug adjustment)
(6) Respiratory dysfunction requiring oxygen administration
(7) Severe heart failure (III or more in NYHA classification)
(8) Active lower respiratory tract infection requiring antibiotic administration
(9) Cases that the physician judged inappropriate
Target sample size 87

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Katori
Organization Graduate School of Medicine, Tohoku University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL +81-22-717-7304
Email yukio.katori.d1@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Kato
Organization Graduate School of Medicine, Tohoku University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL +81-22-717-7304
Homepage URL
Email engekato@gmail.com

Sponsor
Institute Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 10 Month 02 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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
2018 Year 10 Month 02 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039163

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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