UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016896 |
|---|---|
| Receipt number | 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 10:32:22 |
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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
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
kuogasa@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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