UMIN-CTR Clinical Trial

Basic information
Public title	A study of brain activity changes by wearing the Wearable Cyborg HAL in healthy people
Acronym	A study of brain activity changes by HAL
Scientific Title	A study to investigate brain activity changes by wearing the Wearable Cyborg HAL in healthy subjects
Scientific Title:Acronym	A study of brain activity changes by HAL
Region	Japan

Condition
Condition	cerebrovascular disease, spinal cord injury, post-polio syndrome, progressive muscular dystorophy
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the brain activity changes by wearing the Wearable Cyborg HAL in healthy subjects. The Wearable Cyborg HAL improves motor function by wearing the suit and performing motor training in patients with cerebral neurological diseases. This is thought to improve muscle and joint action as well as to change the brain activity. However, there have been no reports on the evaluation of brain activity before, during, and after motor training. Therefore, we will examine the brain activity changes in healthy subjects in order to obtain the basic knowledge.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amplitude values of EEG
Key secondary outcomes	The degree of sensation of being supported in the exercise and the ease of exercise measured by Visual analogue scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subjects between the ages of 18 and 85 years old who have no history of cerebral nerve disease or upper and lower limb movement disorders and have sufficient understanding and consent. In addition, those who physically fit enough to wear the HAL and be able to exercise (walking, squatting, or bending exercise of the elbow) with the HAL are targeted.
Key exclusion criteria	Those who fall under any of the following 1 Those who have uncontrolled cardiovascular disease 2 Those who have uncontrolled respiratory disease 3 Those who have cognitive dysfunction that makes it difficult to understand explanations and instructions 4 Those who have joint disorders such as arthrogryposis 5 Those who have a history of the cranial nerve disorder
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Satoko Middle name Last name Koganemaru
Organization	Graduate School of Medicine Kyoto University
Division name	Human Brain Research Center
Zip code	606-8507
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3695
Email	kogane@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Shima
Organization	Graduate School of Medicine Kyoto University
Division name	Human Brain Research Center
Zip code	606-8507
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3695
Homepage URL
Email	kogane@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Certified Review Board
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyot o
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 12 Month 10 Day
Date of IRB	2021 Year 12 Month 10 Day
Anticipated trial start date	2022 Year 01 Month 19 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is a prospective time series analysis to investigate the brain activity changes induced by exercise using HAL in healthy subjects. First, the subjects exercise without HAL, then exercise with HAL, and again exercise without HAL. One of the following three types of exercise is performed (walking, squatting, or bending exercise of elbow). Brain activity is measured by electroencephalography before, during, and after exercise. The subjective motor sensation is also measured by VAS. Subjects are recruited using the bulletin board in the Kyoto University Co-op and the Silver Human Resource Center. Those who meet the selective criteria, and do not meet the exclusion are informed of the study and given written consent. The recruitment period for the research subjects will be until February 28, 2025.

Management information
Registered date	2022 Year 01 Month 19 Day
Last modified on	2022 Year 01 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053241