UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050849 |
|---|---|
| Receipt number | R000057773 |
| Scientific Title | Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/04/14 15:36:51 |
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Basic information
Public title
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Acronym
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Scientific Title
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Scientific Title:Acronym
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Region
| Japan |
Condition
Condition
cervical spinal cord injury patients
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the detail characteristics of VE in Cervical Spinal Cord Injury patients. And we analyzed the association of VE, and its evaluation and the prognosis of swallowing function as a result of oral intake at discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral intake at discharge
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From january 1st, 2015 to March 31th, 2023, we recruited cervical spinal cord injury inpatients who were diagnosed dysphagia and both undertook dysphagia rehabilitation and VE.
Key exclusion criteria
Exclusion criteria is as follows; patients whose medical chart data did not filfill all of survey items, patients who did not survive at discharge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ohbayashi |
| Middle name | |
| Last name | Shigeru |
Organization
Saitama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 kamoda,kawagoeshi, saitama, Japan.
TEL
049-228-3686
ohbayash@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Taguchi |
| Middle name | |
| Last name | Kazue |
Organization
Saitama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 kamoda,kawagoeshi, saitama, Japan.
TEL
049-228-3686
Homepage URL
k_tagu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
No organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Boards of Saitama Medical center
Address
1981 kamoda,kawagoeshi, saitama, Japan.
Tel
049-228-3902
smcrinri@saitama-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
Other administrative information
Date of disclosure of the study information
| 2023 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From January 2015 to March 2023, we recruited participants admitted to an acute university hospital, and who diagnosed dysphagia and undertook speech therapy and VE. This study investigated the detail characteristics of VE in Cervical Spinal Cord Injury patients. And we analyzed the association of VE, its evaluation(Hyodo score) and the prognosis of swallowing function as a result of oral intake at discharge.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057773
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
