UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043021 |
|---|---|
| Receipt number | R000049112 |
| Scientific Title | Radiological oral assessment for speech-language-hearing rehabilitation in patients with chronic severe traumatic brain injury |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/15 17:37:55 |
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Basic information
Public title
Radiological oral assessment for speech-language-hearing rehabilitation in patients with chronic severe traumatic brain injury
Acronym
Radiological oral assessment for ST rehabilitation in chronic sTBI
Scientific Title
Radiological oral assessment for speech-language-hearing rehabilitation in patients with chronic severe traumatic brain injury
Scientific Title:Acronym
Radiological oral assessment for ST rehabilitation in chronic sTBI
Region
| Japan |
Condition
Condition
Chronic severe traumatic brain injury
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the width of dentition and shape of palatal vault using CT in patients with severe traumatic brain injury to set up optimal speech-language-hearing rehabilitation program
Basic objectives2
Others
Basic objectives -Others
Measurement of characteristic basic intraoral data for patients with chronic severe traumatic brain injury
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
CT measurement of palatal shape, height of maxillary first molar
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects who were hospitalized in our center between March 1st, 2015 and December 31st ,2020
2.Subjects who had available computed tomography (CT) image data including maxillary dentition
Key exclusion criteria
1.Subjects who rejected in the form of optout on the website
2.Subject with CT image defects of maxillary first molar or central incisor or canine tooth
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
TEL
043-277-0061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kojima |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery & Rehabilitation division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
TEL
043-277-0061
Homepage URL
mi-kojima@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Rehabilitation Center for Traumatic Apallics Chiba
Address
3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
Tel
043-277-0061
takahito-seki@chiba-ryougo.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
| 2021 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | 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
retrospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049112
