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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017493
Receipt No. R000020276
Scientific Title Efficacy of consensus guideline on nutritional management and swallowing training for stroke patients with dysphagia
Date of disclosure of the study information 2015/06/01
Last modified on 2018/11/12

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Basic information
Public title Efficacy of consensus guideline on nutritional management and swallowing training for stroke patients with dysphagia
Acronym Efficacy of consensus guideline on nutritional management and swallowing training for stroke patients with dysphagia
Scientific Title Efficacy of consensus guideline on nutritional management and swallowing training for stroke patients with dysphagia
Scientific Title:Acronym Efficacy of consensus guideline on nutritional management and swallowing training for stroke patients with dysphagia
Region
Japan

Condition
Condition Stroke patients with dysphagia who are admitted to convalescent rehabilitation wards
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of the consensus guideline regarding nutritional management and swallowing training for stroke patients with dysphagia in convalescent rehabilitation wards.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Body Mass Index, BMI
Key secondary outcomes Oral intake level
Albumin
Functional Independence Measure, FIM

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Oral care
Indirect and direct dysphagia rehabilitation
Nutritional management
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients over 40 years-old
2. Patients who are not able to meet the required energy and water intake by oral intake alone at their admission.
3. Patients who have given written informed consent by themselves or their representative.
Key exclusion criteria 1. Patiens with supra-tentorial and infra-tentorial stroke lesions.
2. Patients with subarachnoid hemorrhage
3. Patients with severe damage of digestive tract function due to inflammatory bowel disease or short bowel syndrome, etc.
4. Patients had difficulty with food intake due to dysphagia caused by organic disorder, dementia or drugs prior stroke onset.
5. Patients who are decided by physicians as being inappropriate for entry into the present study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Sugawara
Organization Hatsudai Rehabilitation Hospital
Division name Director
Zip code
Address 3-53-3 Honcho, Shibuya-ku, Tokyo 151-0071, Japan.
TEL 03-5365-8500
Email hideyuna@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobukazu Komoribayashi
Organization Iwate Medical University
Division name Department of Neurosurgery
Zip code
Address 19-1 Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Homepage URL
Email nkomorib@iwate-med.ac.jp

Sponsor
Institute Hatsudai Rehabilitation Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 初台リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2015 Year 06 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
2015 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 06 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
2015 Year 05 Month 11 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020276

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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