UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045215 |
|---|---|
| Receipt number | R000051654 |
| Scientific Title | Comparative efficacy of swallowing therapies for dysphasia to prevent pneumonia in patients with acute or subacute stroke: a network meta-analysis of randomized controlled trials |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2021/08/21 12:02:06 |
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Basic information
Public title
Comparative efficacy of swallowing therapies for dysphasia to prevent pneumonia in patients with acute or subacute stroke: a network meta-analysis of randomized controlled trials
Acronym
Swallowing therapies for dysphasia to prevent pneumonia in patients with acute or subacute stroke
Scientific Title
Comparative efficacy of swallowing therapies for dysphasia to prevent pneumonia in patients with acute or subacute stroke: a network meta-analysis of randomized controlled trials
Scientific Title:Acronym
Swallowing therapies for dysphasia to prevent pneumonia in patients with acute or subacute stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Medicine in general | Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare the effectiveness of preventing pneumonia in patients with acute to subacute stroke between a group that received swallowing rehabilitation therapy (treatment A), metoclopramide (treatment B), prophylactic antibiotics (treatment C), and electrical pharyngeal stimulation (treatment D), in addition to standard oral care, and a control group (N) that received standard oral care alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of pneumonia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A randomized controlled trial examining the effect of swallowing therapy on pneumonia prevention in patients with acute or sub-acute strokes.
Key exclusion criteria
observational studies
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa university department of medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
+81-3-3784-8532
koichi-a@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa university department of medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
+81-3-3784-8532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Showa university school 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
Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel
+81-3-3784-8532
koichi-a@med.showa-u.ac.jp
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
| 2021 | Year | 08 | Month | 23 | 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
1179
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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study was to compare the effectiveness of various swallowing treatments in preventing pneumonia in acute and sub-acute stroke patients.
Management information
Registered date
| 2021 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051654
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
