UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045029 |
|---|---|
| Receipt number | R000051426 |
| Scientific Title | Basic research on motor and cognitive learning using virtual reality |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/01 10:58:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hideakim@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051426
