UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046675
Receipt No. R000053241
Scientific Title A study to investigate brain activity changes by wearing the Wearable Cyborg HAL in healthy subjects
Date of disclosure of the study information 2022/01/19
Last modified on 2022/01/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.