臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 01, 2021
Last modified on	Oct. 01, 2021
Trial ID	jRCT1032210357

Scientific Title	Effects of ankle joint motion training using a lower limb exoskeleton robot among hemiplegic patients with stroke
Public Title	Ankle joint motion training using a lower limb exoskeleton robot

Contact for Scientific Queries	Name	Michiyuki Kawakami
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-3353-1211
	E-mail	michiyukikawakami@hotmail.com
Contact for Public Queries	Name	Takayuki Kamimoto
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-3353-1211
	E-mail	rw.mssl.720@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 01, 2021
Target sample size		50
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 patients Hemiplegia due to unilateral cerebral hemisphere lesion Age: 18 years and older Lower limb motor impairment, SIAS(foot pat) 1 or greater Ankle dorsiflexion range of motion is 0 degrees or greater. Patients who do not have severe aphasia or cognitive impairment and can understand the purpose of the study. Patients with no contraindication to exercise therapy.
	Exclusion Criteria	Examples of contraindications to exercise therapy (details are given below) 1) Serious cardiac disease: unstable angina, myocardial infarction of short duration, non-compensated congestive heart failure, acute pulmonary heart, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis, endocarditis, etc. 2) Poorly controlled hypertension (iii) Acute systemic illness or fever (iv) Recent pulmonary embolism, acute pulmonary heart, severe pulmonary hypertension 5) Complication of severe hepatic or renal dysfunction (6) Complication of severe orthopedic disease that interferes with lower limb movement 7) Severe cognitive impairment, severe psychiatric disease (viii) Other metabolic disorders (e.g., acute thyroiditis) (9) Patients with spontaneous pain or inflammation of the ankle joint Patients with a history of ankle fracture or traumatic tendon injury. Patients with contractures of the ankle joint Patients with impaired consciousness (9) Patients for whom written consent could not be obtained
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stroke
Intervention(s)		Rehabilitation using a lower limb exoskeleton robot for 40 minutes per day for 10 days.
Health Condition(s) Keyword		cerebral infarction, Hemorrhagic Strokes
Intervention(s) Keyword		robot rehabilitation
Health Condition(s) Code		D020521
Primary Outcome(s)		Ankle spasticity, motor function (motor paralysis severity and muscle strength)
Secondary Outcome(s)		Motion analysis (ankle joint angle during walking), active Range Of Motion (ROM), surface electromyogram, floor reaction force meter

Source of Monetary Support	CYBERDYNE
Secondary Sponsor	Not applicable

Name of Certified Review Board	Keio Clinical Research Review Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-nintei-jimu@adst.keio.ac.jp
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none