臨床研究等提出・公開システム

Date of registration	Feb. 25, 2019
Last modified on	Oct. 01, 2023
Trial ID	jRCTs052180074

Scientific Title	Clinical utility of cybernic system for patients with neurological diseases causing who need comprehensive nursing care (Clinical utility of cybernic system for patients with neurological diseases causing who need comprehensive nursing care (CUCSPND))
Public Title	Pilot study of cybernic system (Pilot study of cybernic system (PSCS))

Completion date	Feb. 28, 2022
Result actual enrolment	20
Baseline Characteristics	Twenty patients were enrolled to this study. Median age was 70 (44 - 84) years old, 10 male and 10 female, and 15 patients with stroke and 5 postoperative patients.
Participant flow	2019/05/07 First patient in 2022/02/28 Last patient out
Adverse events	No adverse events were reported.
Outcome measures	In the 12 cases in which muscle activity was evaluated, muscle activity was significantly higher in the vastus lateralis muscles during standing training with the waist-mounted HAL than during normal training. In the 8 cases in which safety was evaluated, all patients were able to complete the pre-set 5 sets of sit-to-stand training, and no obvious differences were observed in vital signs or subjective fatigue.
Brief summary	HAL lumber type may increase activity of the quadriceps muscle by increasing support and loading of the hip joint of affected side. The result suggested sit-to-stand training with HAL lumber type may activate the quadriceps muscle of the affected side.
Date of posting of results summaries	Oct. 01, 2023

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs052180074

Contact for Scientific Queries	Name	Miyamoto Susumu
	Affiliation	Kyoto University Graduate school of medicine
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
	Telephone	+81-75-751-3653
	E-mail	miy@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kikuchi Takayuki
	Affiliation	Kyoto University Graduate School of Medicine
	Address	54 Kawahara-cho, Shogoin,Sakyo-ku, Kyoto
	Telephone	+81-75-751-3459
	E-mail	tkik@kuhp.kyoto-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 04, 2019
Actual date of first enrollment		May. 06, 2019
Target sample size		20
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 with CNS injury who are in need for nursing - 15-85 years old - Patients who can understand the informed consent form - Hospitalized in Kyoto University Hospital
	Exclusion Criteria	- Severe contracture, involuntary movement, ataxia or postural reflex impairment - Uncontrolled cardiovascular/respiratory disorders - Severe spasticity - Severe cognitive impairment
	Age Minimum	15age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		neurological disorder
Intervention(s)		Use of Cybernic system
Health Condition(s) Keyword		CNS injury, Nursing
Primary Outcome(s)		Usability of Cybernic system
Secondary Outcome(s)		Occurrence rate of any adverse event or failure during intervention

Source of Monetary Support	ImPACT
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto University Certified Review Board
Address	Yoshidakonoe, Sakyo, Kyoto, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 27, 2018

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Oct. 01, 2023	(this page)	Changes
4	Feb. 19, 2021	Detail	Changes
3	May. 12, 2020	Detail	Changes
2	June. 26, 2019	Detail	Changes
1	Feb. 25, 2019	Detail

List of change history