UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036355 |
|---|---|
| Receipt number | R000041419 |
| Scientific Title | Survey on tongue pressure, posture, limb muscle strength. |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2024/09/19 11:04:11 |
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Basic information
Public title
Survey on tongue pressure, posture, limb muscle strength.
Acronym
Survey on tongue pressure, posture, limb muscle strength.
Scientific Title
Survey on tongue pressure, posture, limb muscle strength.
Scientific Title:Acronym
Survey on tongue pressure, posture, limb muscle strength.
Region
| Japan |
Condition
Condition
Our hospitalized patient who has a prescription for rehabilitation.
Our staff and trainees in rehabilitation department and students from Fukuyama Medical Vocational College who can cooperate in this research.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Find a regression equation that predicts tongue pressure from grip
Basic objectives2
Others
Basic objectives -Others
Knee extension strength, toe grip
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tongue pressure and grip
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
The patient who has obtained written consent by the patient's own free will.
Our staff who can cooperate freely and trainees in rehabilitation department and students from Fukuyama Medical Vocational College who can cooperate in this research.
Key exclusion criteria
When the research leader or research co-worker decides that the participation of this research is not appropriate .
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Matsuzaki |
Organization
Fukuyama city hospital
Division name
Department of Rehabilitation
Zip code
7218511
Address
5-23-1 Zao-cho, Fukuyama City, Hiroshima Prefecture
TEL
0849415151
shibyou-riha@city.fukuyama.hiroshima.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okazaki |
Organization
Fukuyama city hospital
Division name
Department of Rehabilitation
Zip code
7218511
Address
5-23-1 Zao-cho, Fukuyama City, Hiroshima Prefecture
TEL
0849415151
Homepage URL
shibyou-riha@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Fukuyama city hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Fukuyama city hospital Committee
Address
5-23-1 Zao-cho, Fukuyama City, Hiroshima Prefecture
Tel
0849415151
shibyou-rinri@city.fukuyama.hiroshima.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
| 2019 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
46
Results
tongue pressure measuring instruments and grip strength were measured and single regression analysis was conducted using SPSS.
A single regression expression of the healthy person group is Y=0.134*average grip force +38.002, correction R2(0.015), multiple correlation (0.201), and superiority F (0.212).
A single regression formula for the group of hospitalized patients was Y=0.848*average grip force +0341, correction R2 (-0.571), multiple correlation (0.462), and superiority F (0.694).
Results date posted
| 2024 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From November 2018 to November 2021, 43 healthy people and 3 hospitalized patients agreed to use tongue pressure measuring instruments .
Participant flow
Participants who have obtained consent from November 2018 to November 2021 will participate
Adverse events
None
Outcome measures
tongue pressure and grip strength
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 19 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 19 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 19 | Day |
Other
Other related information
completion of an examimnation
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041419
