UMIN-CTR Clinical Trial

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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