UMIN-CTR Clinical Trial

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
Email	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
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056429