UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054884 |
|---|---|
| Receipt number | R000062711 |
| Scientific Title | Relationship between the evaluation of masseter muscle and masticatory function by ultrasonic diagnostic device in patients with severe dysphagia |
| Date of disclosure of the study information | 2024/07/05 |
| Last modified on | 2024/07/05 08:09:49 |
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Basic information
Public title
Relationship between the evaluation of masseter muscle and masticatory function by ultrasonic diagnostic device in patients with severe dysphagia
Acronym
Evaluation of masseter muscle in dysphagia patients by ultrasonography
Scientific Title
Relationship between the evaluation of masseter muscle and masticatory function by ultrasonic diagnostic device in patients with severe dysphagia
Scientific Title:Acronym
Evaluation of masseter muscle in dysphagia patients by ultrasonography
Region
| Japan |
Condition
Condition
Chronic severe brain injury
Classification by specialty
| Oral surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between masseter muscle and masticatory function in patients with severe dysphagia to select the appropriate diet form and to use it as an indicator for rehabilitation
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masseter muscle volume and level determination of feeding and swallowing status
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
Patients eligible for rehabilitation admitted to our center as of April 2024 who can measure masseter muscle by ultrasonography from July 1 to October 30, 2024
Patients or their legal guardians who can give written consent of their own free will after receiving a full explanation of the study
Patients who can measure the masseter muscle at rest
Key exclusion criteria
Patients whose general condition is unstable and who cannot be safely examined
Patients who cannot give written consent
Patients with a history of facial fracture
Patients who are unable to perform the masseter muscle measurement at rest
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miku |
| Middle name | |
| Last name | Kato |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Nursing section
Zip code
261-0012
Address
3-30-1Isobe, Mihama-ku, Chiba-shi, Chiba
TEL
0432770061
m-katou@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Kato |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Nursing section
Zip code
261-0012
Address
3-30-1Isobe, Mihama-ku, Chiba-shi, Chiba
TEL
0432770061
Homepage URL
https://www.chiba-ryougo.jp/
m-katou@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Center for Traumatic Apallics Chiba
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
3-30-1Isobe, Mihama-ku, Chiba-shi, Chiba
Tel
0432770061
y-oomura@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
| 2024 | Year | 07 | Month | 05 | 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
| 2024 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062711
