UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Virtual Reality-guided exercise on Postural Control
Acronym	Effects of Virtual Reality-guided exercise on Postural Control
Scientific Title	Effects of Virtual Reality-guided exercise on Postural Control
Scientific Title:Acronym	Effects of Virtual Reality-guided exercise on Postural Control
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects on postural control before and after the cagula intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	trunk muscle thickness
Key secondary outcomes	Center of gravity sway: total trajectory length, peripheral area plantar sensation head and trunk acceleration

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	mediVR Kagura 20 minutes. /
Interventions/Control_2	reaching exercise. 20 minutes
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	20 years-old <
Age-upper limit	45 years-old >=
Gender	Male
Key inclusion criteria	No back pain, no surgery or injury to the trunk
Key exclusion criteria	Any disease or disorder that makes it difficult to perform the test.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Kudo Middle name Last name Shintarou
Organization	Morinomiya University of Medical Science
Division name	Department of Physical Therapy
Zip code	559-8611
Address	1-26-16 Nankoukita,Suminoe-ku, Osaka-shi, Osaka
TEL	06-6616-6911
Email	kudo@morinomiya-u.ac.jp

Public contact
Name of contact person	1st name Kudo Middle name Last name Shintarou
Organization	Morinomiya University of Medical Science
Division name	Department of Physical Therapy
Zip code	559-8611
Address	1-26-16 Nankoukita,Suminoe-ku, Osaka-shi, Osaka
TEL	06-6616-6911
Homepage URL
Email	kudo@morinomiya-u.ac.jp

Sponsor
Institute	Morinomiya University of Medical Science
Institute
Department

Funding Source
Organization	KAKENHI, JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Morinomiya University of Health Sciences Research Ethics Committee
Address	1-26-16 Nankoukita,Suminoe-ku, Osaka-shi, Osaka
Tel	06-6616-6911
Email	univ@morinomiya-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	2022 Year 08 Month 26 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	Completed
Date of protocol fixation	2022 Year 02 Month 08 Day
Date of IRB	2022 Year 02 Month 08 Day
Anticipated trial start date	2022 Year 08 Month 30 Day
Last follow-up date	2022 Year 12 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	2022 Year 08 Month 22 Day
Last modified on	2022 Year 12 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055512