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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037552
Receipt No. R000042757
Scientific Title Research on the effects of voluntary joint movement and passive joint movement induced by peripheral nerve magnetic stimulation on body specific attention: a basic study for healthy people
Date of disclosure of the study information 2019/07/31
Last modified on 2020/07/30

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Basic information
Public title Research on the effects of voluntary movement and passive movement on the attention to the body: a basic study for healthy people
Acronym Research on the effects of voluntary movement and passive movement on the attention to the body
Scientific Title Research on the effects of voluntary joint movement and passive joint movement induced by peripheral nerve magnetic stimulation on body specific attention: a basic study for healthy people
Scientific Title:Acronym Research on the effects of voluntary joint movement and passive joint movement induced by peripheral nerve magnetic stimulation on body specific attention
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of voluntary joint movement and passive joint movement induced by peripheral magnetic stimulation on body specific attention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Amount of body specific attention to the hand (Amount of attention to the hand)
Key secondary outcomes Experiment 1: Muscle activity of the extensor carpi radialis muscle, Range of motion about hand joint movement, Muscle pain and muscle fatigue of forearm dorsal side
Experiment 2: Perceived self-hand size, Accuracy of memory about joint angle

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 active wrist joint movement with ovserbation
Times: 30
Interventions/Control_2 active wrist joint movement without ovserbation
Times: 30
Interventions/Control_3 not active wrist joint movement with ovserbation
Times: 30
Interventions/Control_4 not active wrist joint movement without ovserbation
Times: 30
Interventions/Control_5 peripheral nerve magnetic stimulation on the deep branch of radial nerve
Times: 36 (stimulate 2s then rest 3s for each time)
Interventions/Control_6 sham peripheral nerve magnetic stimulation on the deep branch of radial nerve
Times: 36 (stimulate 2s then rest 3s for each time)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1.Physically and mentally healthy adults aged 20-40 years old;
2.Agreement to the content of Explanation file
Key exclusion criteria 1.Participant who wears medical devices to support their lives, like cardiac pacemaker, etc.;
2.Diagnosis of maglignant tumor;
3.Women who are pregnant or had given birth to a baby recently;
4.Participants who have the symptoms of infection;
5.Participant who suffers from acute pain;
6.Diabetic patients;
7.Core tempature lower than normal;
8.Disorder of blood circulation;
9.Physical problem of upper limbs;
10.Surgery of upper limbs in the past.
11.Impaired vision including severe poor eyesight, visual field narrowing, and color blindness;
12.A history of central nervous disease or psychiatric disorder such as stroke, head injury, dementia, motor developmental retardation, schizophrenia or co-morbidities;
13.Obstacles in sense or motion of the upper limbs;
14.Subjective symptoms such as severe illusion or poor vision due to overuse of the eyes.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Izumi
Organization Tohoku university
Division name Graduate School of Biomedical Engineering
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7338
Email izumis@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Izumi
Organization Tohoku university
Division name Graduate School of Biomedical Engineering
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7338
Homepage URL
Email izumis@med.tohoku.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

Funding Source
Organization Tohoku university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committees of Tohoku University School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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 07 Month 31 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2024 Year 06 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 07 Month 31 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042757

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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