臨床研究等提出・公開システム

Date of registration	May. 26, 2023
Last modified on	May. 26, 2023
Trial ID	jRCT1070230016

Scientific Title	Effect of VR intervention on cognitive function -Association with visual working memory-
Public Title	Effect of VR intervention on cognitive function -Association with visual working memory-

Contact for Scientific Queries	Name	Sakata Junya
	Affiliation	Medical Corporation Tanakakai Musashigaoka Hospital
	Address	7-15-1 Kusunoki Kumamoto
	Telephone	+81-96-339-1161
	E-mail	zuntaro@icloud.com
Contact for Public Queries	Name	Sakata Junya
	Affiliation	Medical Corporation Tanakakai Musashigaoka Hospital
	Address	7-15-1 Kusunoki Kumamoto
	Telephone	+81-96-339-1161
	E-mail	zuntaro@icloud.com

Recruitment status	Recruiting


Anticipated date of first enrollment		May. 26, 2023
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects were orthopedic patients aged 65 years or older who were able to maintain a sitting position independently during hospitalization in the Rehabilitation of Musashigaoka Hospital, without dementia or cognitive dysfunction (MMSE cut-off value of 24 or higher). The patient must be able to hold the controller with both upper limbs and reach to 90 degree shoulder flexion and maximum elbow extension.
	Exclusion Criteria	Those who could not understand the explanation of this research or could not obtain consent were excluded from the study. Inpatients under the age of 65, severely impaired motor function, dementia (MMSE cutoff value of 23 points or less), and cognitive dysfunction due to stroke are excluded.
	Age Minimum	65age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Orthopedic disease
Intervention(s)		The falling task will be performed using mediVR Kagura. The intervention period will be 3 weeks, 4 sessions/week (12 sessions in total), 10 minutes per session x 2 sets for a total of about 20 minutes. The number of trials per session (20 minutes) was set to 200, and when the achievement rate exceeded 80 percent, the task sense was gradually narrowed down (up to a maximum of 20 minutes). The number of trials per session (20 minutes) is approximately 200, and once the achievement rate exceeds 80 percent, the task sense is gradually narrowed down (up to 400 trials per session).
Primary Outcome(s)		Timed Up & Go Test (TUG) Functional Reach Test (FRT) Mini Mental State Examination (MMSE) Trail Making Test (TMT-A, B) Visio-spatial memory test N-back task digit span (forward, backward)

Primary Sponsor	Medical Corporation Tanakakai Musashigaoka Hospital

Name of Certified Review Board	Medical Corporation Tanakakai Musashigaoka Hospital Ethics Board
Address	7-15-1 Kusunoki Kumamoto, Kumamoto
Telephone	+81-96-339-1161
E-Mail	zuntaro@icloud.com
Approval Status	Approval
Date of approval	April. 07, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none