UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012475 |
|---|---|
| Receipt number | R000014579 |
| Scientific Title | Study of Algorithm for Post-stroke Patients to improve oral intake Level |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2020/12/21 15:06:33 |
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Basic information
Public title
Study of Algorithm for Post-stroke Patients to improve oral intake Level
Acronym
APPLE study
Scientific Title
Study of Algorithm for Post-stroke Patients to improve oral intake Level
Scientific Title:Acronym
APPLE study
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to obtain data contributing to plan an algorithm of nutrition and rehabilitation managements to improve oral intake level in stroke patients. Patients with factors at high risk for dysphagia for acute stroke are prospectively enrolled into the present study. All the enrolled patients undergo direct and indirect trainings of swallowing in the early stage of stroke onset; and screening and further examination of swallowing function at the same time. Subsequently, we compare results of the above protocol with previous retrospective data without interventions and evaluate exploratory safety and efficacy of the protocol with early interventions for dysphagia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of development of aspiration pneumonia during hospitalization
Key secondary outcomes
1. Oral intake level (grade of oral intake and degree of dysphagia on discharge; presence or absence of oral intake during hospitalization; term from admission to start of oral intake)
2. Nutrition indicators (chronological changes of BMI, albumin, total protein, total count of lymphocyte)
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 training for dysphagia
Repetitive saliva swallowing test, RSST
Modified water swallow test, MWST
Food test, FT
Direct training for dysphagia
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. NIHSS of 10 to 30 on admission
2. mRS of 0 or 1 prior stroke onset
3. Patients who can orally take three meals per a day and do not need to be thickened for water intake prior stroke onset
Key exclusion criteria
1. Patiens with supra-tentorial and infra-tentorial stroke lesions.
2. Patients with subarachnoid hemorrhage
3. Patients with severe aspiration pneumonia or suffocation on admission.
4. Patients with severe damage of digestive tract function due to inflammatory bowel disease or short bowel syndrome, etc.
5. Patients with impossible oral intake due to severe dysphagia caused by organic disorder, dementia or drugs prior stroke onset.
6. Patients who are decided by physicians as being inappropriate for entry into the present study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ogawa |
Organization
Iwate Medical University
Division name
Department of Neurosurgery
Zip code
020-8505
Address
19-1 Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
president@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Kuniaki |
| Middle name | |
| Last name | Ogasawara |
Organization
Iwate Medical University
Division name
Department of Neurosurgery
Zip code
020-8505
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
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
19-1, Uchimaru, Morioka, Iwate, Japan
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.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
岩手医科大学附属病院（岩手県）
川崎医科大学附属病院（岡山県）
川崎医科大学附属川崎病院（岡山県）
独立行政法人労働者健康福祉機構中国労災病院（広島県）
独立行政法人国立病院機構呉医療センター・中国がんセンター（広島県）
医療法人光臨会荒木脳神経外科病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014579
