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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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Interventions/Control_1 | active wrist joint movement with ovserbation
Times: 30 |
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Interventions/Control_2 | active wrist joint movement without ovserbation
Times: 30 |
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Interventions/Control_3 | not active wrist joint movement with ovserbation
Times: 30 |
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Interventions/Control_4 | not active wrist joint movement without ovserbation
Times: 30 |
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Interventions/Control_5 | peripheral nerve magnetic stimulation on the deep branch of radial nerve
Times: 36 (stimulate 2s then rest 3s for each time) |
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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) |
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Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku university
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Division name | Graduate School of Biomedical Engineering | ||||||
Zip code | 980-8575 | ||||||
Address | 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi | ||||||
TEL | 022-717-7338 | ||||||
izumis@med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |