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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022632
Receipt No. R000026085
Scientific Title Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb
Date of disclosure of the study information 2016/06/07
Last modified on 2020/10/06

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Basic information
Public title Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb
Acronym Effect of magnetic and electrical stimulation on upper limb
Scientific Title Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb
Scientific Title:Acronym Effect of magnetic and electrical stimulation on upper limb
Region
Japan

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

Objectives
Narrative objectives1 To clarify the relationship between stimulus condition and movement of wrist joint on the magnetic and electrical stimulation for upper limb
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of joint angle of wrist
Key secondary outcomes Pain and discomfort score (numerical rating scale; NRS)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Magnetic stimulation device and electrical stimulation device are used once in the same day. The stimulation frequency is 30Hz, stimulation time is two seconds per once, and number of times is 4 times per stimulation condition.
Interventions/Control_2 Electrical stimulation device was used once in the same day. The stimulation frequency is 30Hz, stimulation time is two seconds per once, and number of times is 4 times per stimulation condition.
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy person
Key exclusion criteria User of the medical electrical equipment (pacemaker, pump oxygenator equipment and electrocardiogram), cancer, pregnancy, infectious disease, esthesiodermia or skin abnormality, indistinct intention, acute algetic disease, diabetes, hypothermia, hematogenous disorders
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Shin-ichi
Organization Tohoku University
Division name Department of Physical medicine and Rehabilitation, School of Medicine/ Graduate of School of Biomedical Engineering
Zip code 980-8575
Address 2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL 022-717-7338
Email izmis@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Oyama
Middle name
Last name Hideki
Organization Tohoku University
Division name Department of Physical medicine and Rehabilitation, Graduate of School of Biomedical Engineering
Zip code 980-8575
Address 2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL 022-717-7338
Homepage URL
Email oyama@bme.tohoku.ac.jp

Sponsor
Institute School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Tohoku University Hospital Clinical Research Ethics Committee
Address 2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
Tel 022-717-7145
Email rinri-2@proj.med.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 東北大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 07 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled 12
Results rTMS caused less pain and discomfort than TES, but this was only evident when comparatively large joint movements occurred.
Results date posted
2020 Year 09 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The subjects were 12 healthy adults with no neurological abnormalities of the arms. The group was comprised of 7 men and 5 women with a mean age of 23.0. All subjects were right-handed according to the Edinburgh inventory of handedness.
Participant flow Of all subjects, half of the subjects performed in the order of rPMS condition to TES condition. Another half of the subjects performed in the order of TES condition to rPMS condition.
Adverse events None.
Outcome measures Dorsiflexion angle of the wrist joint. Pain and discomfort using a numerical rating scale.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 01 Day
Date of IRB
2017 Year 07 Month 07 Day
Anticipated trial start date
2017 Year 07 Month 07 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2020 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026085

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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