UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017493 |
|---|---|
| Receipt number | 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 12:49:42 |
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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
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
nkomorib@iwate-med.ac.jp
Sponsor or person
Institute
Hatsudai Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020276
