UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037552 |
|---|---|
| Receipt number | 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 | 2023/08/12 13:48:56 |
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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
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
izumis@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
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
| 2019 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-3417/12/10/5250
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3417/12/10/5250
Number of participants that the trial has enrolled
39
Results
Real repetitive peripheral magnetic stimulation enlarged the implicit body representation of the hand within the plausible range of a real hand, while sham repetitive peripheral magnetic stimulation didn't show such an effect.
Results date posted
| 2023 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 23 | Day |
Baseline Characteristics
Young healthy participants recruited from Tohoku University
Participant flow
Recruitment of participants-randomization of groups-measurement of implicit body representation-real repetitive peripheral magnetic stimulation or sham repetitive peripheral magnetic stimulation-measurement of implicit body representation-observation of side effects
Adverse events
None
Outcome measures
Implicit body representation of the hand
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042757
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/08/12 | 研究計画書倫理委員会.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/08/12 | research data sample.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/08/12 | research data of implicit body representation.xls |
