UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049642 |
|---|---|
| Receipt number | R000056429 |
| Scientific Title | Development of a balance training system that can improve the static and dynamic balance ability of the elderly |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2022/12/01 22:23:32 |
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Basic information
Public title
Development of a balance training system that can improve the static and dynamic balance ability of the elderly
Acronym
Development of a balance training system that can improve the static and dynamic balance ability of the elderly
Scientific Title
Development of a balance training system that can improve the static and dynamic balance ability of the elderly
Scientific Title:Acronym
Development of a balance training system that can improve the static and dynamic balance ability of the elderly
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a balance training system that can improve static and dynamic balance ability for the elderly by using VR and to clarify its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic subject information (age, height, weight, medical history, current medical history)
Subject's physical function evaluation (Brunnstrom stage, joint mobility, muscle strength, balance ability, etc.)
Test data (plantar pressure center position, area of center of gravity sway, stability limit)
Images and video recordings of the test
The medical records will be used as the experimental data for the basic information and physical function evaluation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. static training system effectiveness test
Objective: To test whether the static balance ability can be improved by improving the Sensory Reweighting ability.
Duration: 14 minutes
Experimental condition: Standing position
Experimental method:
Subjects performed static balance training using the system for 40 seconds x 5 times, and their sensory reweighing ability and static balance ability were compared before and after the training.
Measurement items:
Plantar pressure center position, area of center of gravity sway in static standing position, video and audio during the test
Interventions/Control_2
2. dynamic training system effectiveness test
Objective: To verify whether dynamic balance ability can be improved by extending the stability limit through load transfer training.
Duration: 10 minutes
Experimental condition: Standing
Experimental method:
Play a game in a VR space while using a dynamic balance training system, and compare the dynamic balance ability before and after the game.
Measurement items:
Plantar pressure center position, area of maximum center of gravity shift in front-back and left-right directions, video and audio during the test
Interventions/Control_3
3. A validation test will be conducted to verify the usefulness of the static training system. The experiment will be conducted without the vibration of the vibrating belt. After the completion of each condition, the static balance and sensory reweighting abilities measured in the Pre-test and Post-test will be compared and evaluated respectively. (40 seconds x 5 times)
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy elderly persons who wish to use this system and meet the following criteria: 1.
1. have the communication skills to understand the instructions of the experimenter
2. live independently in the community
3. Able to stand on one leg and maintain balance for at least 30 seconds
4. Able to walk without aids.
5. Mini-mental state test score of 20 or more (no dementia)
6. Ability to sense the vibration of the BF system.
Key exclusion criteria
1.cerebrovascular accident
2.cerebral trauma
3.Parkinson's disease
4.Acute infectious disease
5.Significant orthopedic impairment
6.Severe visual or hearing impairment
7.Nerve damage
8.Physical pain
9.History of syncope
10.Obesity >30 kg/m2
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
Room 603, Green Computing Systems Research Organization, Bldg. 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
Room 603, Green Computing Systems Research Organization, Bldg. 40, Waseda University, 27 Waseda-cho,
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University Ethics Review Committee
Address
2nd floor, No. 9 Bldg.1-104 Totsuka -cho, Shinjuku-ku, Tokyo 162-0044, Japan
Tel
03-5272-1639
rinri@list.waseda.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
| 2022 | Year | 12 | Month | 08 | 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
| 2022 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056429
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