UMIN-CTR Clinical Trial

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
Email	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
Email	kuogasa@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014579