UMIN-CTR Clinical Trial

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
Email	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
Email	mi-kojima@chiba-ryougo.jp

Sponsor
Institute	Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049112