UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049972 |
|---|---|
| Receipt number | R000056902 |
| Scientific Title | Examination of new balance evaluation equipment |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/01/06 09:59:41 |
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Basic information
Public title
Examination of new balance evaluation equipment
Acronym
Examination of new balance evaluation equipment
Scientific Title
Examination of new balance evaluation equipment
Scientific Title:Acronym
Examination of new balance evaluation equipment
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diabetes is on the rise worldwide, and Japan is no exception. Diabetes is a problem because of its complications. In addition to proper blood sugar control, it is important to maintain blood pressure, lipid metabolism, and body weight in order to prevent complications and prevent their progression.In addition, rehabilitation plays a major role. After determining the goal of blood sugar control, it is necessary to select the optimal method and obtain sufficient effects while avoiding hypoglycemia in order to proceed with drug therapy and exercise therapy. This research is planned based on the idea that it is necessary to evaluate disabilities more quickly.The force plate we use in this study is designed to measure the force acting between the floor and the foot when a person moves against gravity. (reaction force) can be measured. By measuring this reaction force, it is possible to clarify in which direction and how much force is generated by human motion, and to calculate the force and moment applied on the plate. Therefore, the purpose of this study was to clarify the characteristics of patients with balance disorders from the variation in posture and the dispersion of ankle joint moment when holding a standing position. We will evaluate the balance function using the force plate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posture angle and ankle joint moment measurement using force plate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
You get on top of a device with two force plates and apply constant frequency induction to keep your posture. The measurement time is scheduled to be 1 minute. At this time, he was careful not to fall over, and he wore a helmet while the researcher was nearby. In addition, parallel bars will be installed to ensure safety. Criteria for discontinuation are those who lose their balance significantly at the time of measurement, and those who complain of feeling unwell.
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 hospitalized with diabetes who can maintain a stable standing posture
Key exclusion criteria
Subjects who lose their balance significantly during measurement, or who complain of feeling unwell
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | RYO |
| Middle name | |
| Last name | YAMAMOTO |
Organization
Kochi University Hospital
Division name
rehabilitation department
Zip code
7838505
Address
185-1 , Kohasu,Okatoyo-cho, Nankoku City, Kochi Prefecture
TEL
0888665811
jm-ryo-yamamoto@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | RYO |
| Middle name | |
| Last name | YAMAMOTO |
Organization
Kochi University Hospital
Division name
rehabilitation department
Zip code
7838505
Address
185-1 , Kohasu,Okatoyo-cho, Nankoku City, Kochi Prefecture
TEL
0888665811
Homepage URL
jm-ryo-yamamoto@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University of Technology
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
Kochi University
Address
185-1 , Kohasu,Okatoyo-cho, Nankoku City, Kochi Prefecture
Tel
0888665811
jm-ryo-yamamoto@kochi-u.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 | 01 | Month | 13 | 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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056902
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
