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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016896
Receipt No. R000019610
Scientific Title Efficacy of consensus guideline on nutritional management and swallowing training for acute and subacute stroke patients
Date of disclosure of the study information 2015/04/30
Last modified on 2016/08/01

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Basic information
Public title Efficacy of consensus guideline on nutritional management and swallowing training for acute and subacute stroke patients
Acronym APPLE Study
Scientific Title Efficacy of consensus guideline on nutritional management and swallowing training for acute and subacute stroke patients
Scientific Title:Acronym APPLE Study
Region
Japan

Condition
Condition Acute stroke
Classification by specialty
Neurology Neurosurgery Adult
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 acute and subacute stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase II

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
Food Maneuver Other
Interventions/Control_1 Oral care
Indirect methods
Repetitive saliva swallowing test , RSST
Modified water swallow test, MWST
Food test, FT
Direct training
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. NIHSS on admission: from 10 to 30
2. mRS before stroke: from 0 to 1
3. Patients orally can take food without water intake before stroke.
Key exclusion criteria 1. Both supra-tentorial and infral-tentorial lesions.
2. Definite subarachnoid hemorrhage
3. Digestive tract function reducing due to inflammatory bowel disease or short bowel syndrome.
4. Oral intake is difficult due to dysphagia, drug-induced organic disorder, or dementia before stroke.
5. Inappropriate by physician.
Target sample size 125

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Ogawa
Organization Iwate Medical University
Division name Department of Neurosurgery
Zip code
Address 19-1 Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Email president@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniaki Ogasawara
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 kuogasa@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
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
2015 Year 04 Month 30 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 12 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2016 Year 09 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 24 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019610

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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