臨床研究等提出・公開システム

Date of registration	May. 30, 2025
Last modified on	May. 30, 2025
Trial ID	jRCT1042250042

Scientific Title	A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study.
Public Title	A robotic finger training system to facilitate repetitive exercise: a feasibility study.

Contact for Scientific Queries	Name	Otaka Yohei
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
	Telephone	+81-562-93-2167
	E-mail	rehabmed@fujita-hu.ac.jp
Contact for Public Queries	Name	Ushizawa Kazuki
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
	Telephone	+81-562-93-2167
	E-mail	kazuki.ushizawa@fujita-hu.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 14, 2021
Actual date of first enrollment		Aug. 17, 2021
Target sample size		30
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	Stroke survivors with motor impairment in finger who consulted a rehabilitation department.
	Exclusion Criteria	General condition is unstable and possibility of sudden change Limited range of motion in fingers or wrist Cognitive impairment that interferes the exercise or objective assessment
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stroke
Intervention(s)		Repetitive finger flexion-extension movement using a robot
Primary Outcome(s)		Subjective assessment (five scale rating)
Secondary Outcome(s)		1. Fugl-Meyer Assessment 2. Action Research Arm Test 3. Modified Ashworth Scale 4. Stroke Impairment Assessment Set 5. Range of motion 6. Electromyogram

Source of Monetary Support	New Energy and Industrial Technology Development Organization (NEDO)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Review Committee of Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Aichi
Telephone	+81-562-93-2865
E-Mail	f-irb@fujita-hu.ac.jp
Approval Status	Approval
Date of approval	July. 13, 2021

Plan to share IPD	No

Secondary ID(s)	UMIN000050491
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	none