UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022632 |
|---|---|
| Receipt number | 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 | 2023/08/04 08:40:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
oyama@bme.tohoku.ac.jp
Sponsor or person
Institute
School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Suspended
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
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026085
