UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034356 |
|---|---|
| Receipt number | 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 11:17:42 |
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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
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
engekato@gmail.com
Sponsor or person
Institute
Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039163
