UMIN-CTR Clinical Trial

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
Email	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
Email	koichi-a@med.showa-u.ac.jp

Sponsor
Institute	Showa university school of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051654