UMIN-CTR Clinical Trial

Basic information
Public title	Effects of exercise in a virtual reality (VR) space on motor and cognitive learning
Acronym	Effects of exercise in a virtual reality (VR) space on motor and cognitive learning
Scientific Title	Basic research on motor and cognitive learning using virtual reality
Scientific Title:Acronym	Basic research on motor and cognitive learning using virtual reality
Region	Japan

Condition
Condition	Healthy adults between 20 and 80 years of age
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the process of motor learning in healthy adults using virtual reality (VR), real-life, and VR combined with transcranial direct current electrical stimulation (tDCS). By clarifying the learning process in VR and real life, and whether or not tDCS can affect learning, we can provide basic information for future application to actual cases of central nervous system diseases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Box and Block Test (measurement of the number of blocks that can be carried in one minute) will be conducted before and after each intervention condition to examine the effectiveness.
Key secondary outcomes	Motor evoked potentials to evaluate the excitability of the corticospinal tract, cognitive tasks (Kohs block design test, Rey-Osterrieth Complex Figure Test, nasal finger-nose test, BIT (Behavioral Inattention Test) imitation task), and motor tasks (Simple Test for Evaluating Hand Function) will be conducted before and after each intervention condition.

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	20 minutes of exercise task in the real world => 1 week of washout period => 20 minutes of exercise task in VR space => 1 week of washout period => 20 minutes of exercise task in VR space + tDCS. The VR device is a Leap Motion Controller (80mm x 30mm x 11mm) manufactured by Leap Motion. When the user moves his/her fingers in front of the sensor camera, the fingers on the PC screen move in real time. The exercise task is performed in this VR space. The tDCS device is the GD-800 Compact-DC Stimulator (75mm x 75mm x 44mm, 140g) manufactured by OG Giken. An electrode pad (5cm x 7cm) is placed on the head non-invasively, and a weak current with a stimulus intensity of 1 or 2mA or less is applied for about 20 minutes.
Interventions/Control_2	20 minutes of exercise task in the real world => 1 week of washout period => 20 minutes of exercise task in VR space + tDCS => 1 week of washout period => 20 minutes of exercise task in VR space.
Interventions/Control_3	20 minutes exercise task in VR space => 1 week washout period => 20 minutes exercise task in real world => 1 week washout period => 20 minutes exercise task in VR space + tDCS.
Interventions/Control_4	20 minutes exercise task in VR space => 1 week washout period => 20 minutes exercise task in VR space + tDCS => 1 week washout period => 20 minutes exercise task in real world.
Interventions/Control_5	20 minutes of exercise task in VR space + tDCS => 1 week of washout period => 20 minutes of exercise task in VR space => 1 week of washout period => 20 minutes of exercise task in real world.
Interventions/Control_6	20 minutes of exercise task in VR space + tDCS => 1 week of washout period => 20 minutes of exercise task in real world => 1 week of washout period => 20 minutes of exercise task in VR space.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Those who have received sufficient explanations about participation in this study and have obtained the written consent of the subject of their own free will with full understanding.
Key exclusion criteria	Subjects who fall under any one of the following are excluded. (1) Subjects with a history of epilepsy (2) Do not have a history of central nervous system disease or motor system disease that causes functional impairment of the upper limbs. (3) Pregnant women, those who may be pregnant, or those who are breastfeeding. (4) Those who have participated in other clinical trials within the past 4 months. (5) Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Matsuo
Organization	University of Fukui hospital
Division name	Division of Physical Therapy and Rehabilitation Medicine
Zip code	910-1193
Address	Matsuoka Shimoaizuki 23, Eiheiji, Fukui
TEL	0776613111
Email	hideakim@u-fukui.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Matsuo
Organization	University of Fukui hospital
Division name	Division of Physical Therapy and Rehabilitation Medicine
Zip code	910-1193
Address	Matsuoka Shimoaizuki 23, Eiheiji, Fukui
TEL	0776613111
Homepage URL
Email	hideakim@u-fukui.ac.jp

Sponsor
Institute	University of Fukui hospital
Institute
Department

Funding Source
Organization	University of Fukui hospital
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	The Research Ethics Committee of University of Fukui
Address	Matsuoka Shimoaizuki 23, Eiheiji, Fukui
Tel	0776613111
Email	chiken@ml.u-fukui.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	2021 Year 09 Month 01 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	2021 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2023 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	2021 Year 08 Month 01 Day
Last modified on	2021 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051426