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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036780
Receipt No. R000041912
Scientific Title Interaction between brain activity and reaching trajectory during physical guidance
Date of disclosure of the study information 2019/05/24
Last modified on 2019/05/17

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Basic information
Public title Interaction between brain activity and reaching trajectory during physical guidance
Acronym Interaction between brain activity and reaching trajectory during physical guidance
Scientific Title Interaction between brain activity and reaching trajectory during physical guidance
Scientific Title:Acronym Interaction between brain activity and reaching trajectory during physical guidance
Region
Japan

Condition
Condition healthy and neurologically intact
adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate relation between brain activity and reaching trajectory during physical guidance.
Basic objectives2 Others
Basic objectives -Others Electroencephalographic oscillations and coordinates of hand and arm positions.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalographic oscillations and coordinates of hand and arm positions are recorded during physical guidance.
Key secondary outcomes

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 Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Subjects are seated with their hands and forearms resting on a pillow on the desk.
Transcranial magnetic stimulation is used to search for the biceps hot spot and to determine the position of the electroencephalographic electrodes. The electrodes are attached to nine places centered on the hot spot. Infrared reflective markers are also attached on participant's right index finger tip, lateral humeral epicondyle, and acromion. In observation condition, participants are asked to observe the first-person perspective video clips, which display elbow flexion and extension movements by physical assistance. In physical guidance condition, the participants are instructed to relax their hand and arm during elbow flexion and extension movements by physical assistance. Each condition comprises 30 trials of 8 movement cycles including elbow flexion and extension.
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
50 years-old >=
Gender Male and Female
Key inclusion criteria The subjects ate healthy, neurologically intact, right-handed volunteers. In addition, screening shows that none are at risk for adverse events during transcranial magnetic stimulation.
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Suzuki
Organization Saitama Prefectural University
Division name School of Health and Social Services
Zip code 3438540
Address 820 Sannomiya, Koshigaya City, Saitama
TEL 048-973-4125
Email suzuki-takako@spu.ac.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Suzuki
Organization Saitama Prefectural University
Division name School of Health and Social Services
Zip code 3438540
Address 820 Sannomiya, Koshigaya City, Saitama
TEL 048-973-4125
Homepage URL
Email suzuki-takako@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research ethics committee of the Saitama Prefectural University
Address 820 Sannomiya, Koshigaya City, Saitama
Tel 048-973-4120
Email shorei@spu.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 24 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
2019 Year 05 Month 08 Day
Date of IRB
2019 Year 03 Month 28 Day
Anticipated trial start date
2019 Year 05 Month 13 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 17 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041912

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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