UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052126 |
|---|---|
| Receipt number | R000059476 |
| Scientific Title | Understanding the mechanisms of human motor control and developing protocols to enhance the activity of residual sensorimotor pathways using neurophysiological techniques |
| Date of disclosure of the study information | 2023/09/06 |
| Last modified on | 2023/09/06 06:55:47 |
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Basic information
Public title
Understanding the mechanisms of human motor control and developing protocols to enhance the activity of residual sensorimotor pathways using neurophysiological techniques
Acronym
Understanding the mechanisms of human motor control and developing the protocols for rehabilitation
Scientific Title
Understanding the mechanisms of human motor control and developing protocols to enhance the activity of residual sensorimotor pathways using neurophysiological techniques
Scientific Title:Acronym
Understanding the mechanisms of human motor control and developing the protocols for rehabilitation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of electrical, magnetic, and vibration stimulation on nervous system and motor function in healthy subjects
Basic objectives2
Others
Basic objectives -Others
Basic science research for clinical application
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor evoked potential
Key secondary outcomes
Electroencephalography, Electromyography, Muscle strength, Voluntary motor function, Balance, Motion analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-invasive electrical, magnetic, and vibration stimulation
Interventions/Control_2
Sham stimulation
Interventions/Control_3
Control
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who have agreed to participate in our research study
Key exclusion criteria
1. Medical history of orthopedic disease
2. Medical history of neurological disease
3. Implanted electronic pacing or defibrillation devices
4. Medical history of epilepsy and febrile convulsion (including family history)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Nito |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
990-2212
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
TEL
023-686-6611
mnito@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Nito |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
991-2212
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
TEL
023-686-6611
Homepage URL
mnito@yachts.ac.jp
Sponsor or person
Institute
Yamagata Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Yamagata Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Yamagata Prefectural University of Health Sciences
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
Tel
023-686-6611
kyogaku@yachts.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
| 2023 | Year | 09 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
