UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The physiological effects of the supportive robotic device, HAL: hemodynamic responses of healthy adult during the motion with the HAL single joint type
Title of the study (Brief title)	The hemodynamic responses by the HAL single joint type
Region	Japan

Condition
Condition	Health adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To promote a better understanding for robotic application, we evaluate the hemodynamic responses as a physiological adaptation during the motion with or without a HAL single joint type.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The hemodynamic responses by near-infrared spectroscopy
Key secondary outcomes	EMG, subjective assessment of HAL use

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The motion with HAL
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	29 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) healthy adults (20-29 years-old) (2) voluntary participation by signboard (3) obtaining the informed consent following the understanding of the research
Key exclusion criteria	(1) patient with orthopedic diseases related to the task-difficulties (2) diagnosis experience of psychiatry or neurology (3) student belonging to the researcher's class (4) judgement as an unsuitable subject by the principal investigator or researcher
Target sample size	45

Research contact person
Name of lead principal investigator	Urakawa Susumu
Organization	Hiroshima Univ
Division name	Dept of Musculoskeletal Functional Research and Regeneration
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5430
Email	urkawas@hiroshima-u.ac.jp

Public contact
Name of contact person	Urakawa Susumu
Organization	Hiroshima Univ
Division name	Dept of Musculoskeletal Functional Research and Regeneration
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5430
Homepage URL
Email	urkawas@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima Univ
Institute
Department

Funding Source
Organization	Hiroshima Univ
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028540