臨床研究等提出・公開システム

Japanese

Date of registration	June. 03, 2026
Last modified on	June. 03, 2026
Trial ID	jRCT1020260011

Scientific Title	Preliminary Evaluation of Sensory Feedback Intervention Using the Yubi Recorder for Post-Stroke Finger Sensory Impairment
Public Title	A Study Investigating the Effects of the Yubi Recorder on Finger Sensory Impairment After Stroke

Contact for Scientific Queries	Name	Kimura Yuto
	Affiliation	Japan Healthcare University
	Address	1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-351-6100
	E-mail	yuto-kimura@jhu.ac.jp
Contact for Public Queries	Name	Kimura Yuto
	Affiliation	Hirosaki University
	Address	66-1 Honcho, Hirosaki, Aomori, Japan
	Telephone	+81-172-39-5470
	E-mail	jm5470@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 03, 2026
Target sample size		5
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients receiving outpatient/day rehabilitation services who have finger sensory impairment following stroke.
	Exclusion Criteria	1. Participants who withdraw their consent. 2. Patients with normal sensory function in the fingers of the paretic hand. 3. Patients who have difficulty manipulating objects due to the absence of voluntary finger contraction. 4. Patients for whom assessment or intervention is difficult due to impaired consciousness, aphasia, or cognitive impairment.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stroke
Intervention(s)		Intervention frequency and duration: The intervention will be conducted twice weekly for 2 weeks (4 sessions in total), with each session lasting 30 minutes. Yubi Recorder setup: The Yubi Recorder sensor will be attached to the distal interphalangeal (DIP) joint of the paretic index finger, and the vibration transducer will be placed on the paretic side of the neck. Training tasks: 1. Block stacking task (10 minutes): Participants will stack square blocks used in the Kohs Block Design Test using the paretic hand. 2. Sponge discrimination task (10 minutes): Participants will use the volar surface of the paretic index finger to discriminate between sponges of different hardness levels. 3. Pegboard task (10 minutes): Participants will insert pegs into a pegboard using the paretic hand.
Primary Outcome(s)		Semmes Weinstein Monofilament, Grasping force
Secondary Outcome(s)		Fugl-Meyer Assessment, Simple Test for Evaluating Hand Function, Motor Activity Log, Numerical Rating Scale, Modified Ashworth Scale

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Committee of the Graduate School of Health Sciences, Hirosaki University
Address	66-1 Honcho, Hirosaki-shi, Aomori, Japan, Aomori
Telephone	+81-172-39-5911
E-Mail	jm5470@hirosaki-ac.jp
Approval Status	Approval
Date of approval	May. 22, 2026

Plan to share IPD	Yes
Plan description	All data collected in this study will be used solely for the purposes of this research and will be accessible only to the principal investigator and co-investigators. Paper-based records will be securely stored in a locked cabinet within the research laboratory at Japan Healthcare University and will be promptly converted into electronic format. Electronic data will be encrypted and stored on a USB storage device kept in a non-networked computer located in a locked room at Japan Healthcare University. The USB storage device will also be stored in a locked location. Only anonymized data with all personal identifiers removed will be shared among co-investigators. When data are shared, encrypted USB storage devices will be used. If a USB storage device must be transported outside the university, the principal investigator will carry it in a locked case and maintain custody at all times. After completion of the study, research data will be retained for 10 years. Shared datasets held by co-investigators will also be retained for 10 years. Upon expiration of the retention period, paper records will be destroyed using a shredder, and electronic data will be permanently deleted to prevent recovery.

Plan to share IPD

Yes

Plan description

All data collected in this study will be used solely for the purposes of this research and will be accessible only to the principal investigator and co-investigators. Paper-based records will be securely stored in a locked cabinet within the research laboratory at Japan Healthcare University and will be promptly converted into electronic format. Electronic data will be encrypted and stored on a USB storage device kept in a non-networked computer located in a locked room at Japan Healthcare University. The USB storage device will also be stored in a locked location. Only anonymized data with all personal identifiers removed will be shared among co-investigators. When data are shared, encrypted USB storage devices will be used. If a USB storage device must be transported outside the university, the principal investigator will carry it in a locked case and maintain custody at all times. After completion of the study, research data will be retained for 10 years. Shared datasets held by co-investigators will also be retained for 10 years. Upon expiration of the retention period, paper records will be destroyed using a shredder, and electronic data will be permanently deleted to prevent recovery.

Countries of Recruitment（Except Japan）	none