UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046675 |
|---|---|
| Receipt number | 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 18:10:04 |
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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
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
kogane@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053241
