UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057632 |
|---|---|
| Receipt number | R000064893 |
| Scientific Title | Effect of high-frequency repetitive sole stimulation on somatosensory cortex excitability |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/04/16 18:33:35 |
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Basic information
Public title
Effect of high-frequency repetitive sole stimulation on somatosensory cortex excitability
Acronym
Effects of sensory stimulation to the sole of the foot on excitability of the cerebral cortex and spinal cord
Scientific Title
Effect of high-frequency repetitive sole stimulation on somatosensory cortex excitability
Scientific Title:Acronym
Effect of high-frequency repetitive sole stimulation on somatosensory cortex excitability
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Visual, vestibular, and somatosensory information input plays a major role in human balance function, and it has been shown that the somatosensory system, particularly the plantar sense, is involved in balance. Previous research has revealed that high-frequency repetitive sensory stimulation of the soles of the feet improves static balance function in young healthy individuals. However, the mechanism behind this effect has not been verified. Previous research on the upper limbs (fingers) has reported that high-frequency repetitive sensory stimulation not only improves sensory-motor function, but also increases the amplitude of somatosensory evoked potentials. Since an increase in the amplitude of somatosensory evoked potentials indicates an increase in somatosensory cortical excitability, it has been suggested that changes in the central nervous system, including changes in cerebral cortical excitability, are involved in improving sensory-motor function of the upper limbs. However, it is unclear whether changes in the central nervous system, including the somatosensory cortex, are involved in the background of the improvement of static balance function by high-frequency repetitive sensory stimulation of the soles of the feet. The purpose of this study is to verify the effect of high-frequency repetitive sensory stimulation of the soles of the feet on somatosensory cortical excitability in young healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Somatosensory evoked potentials
Body sway
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Electrical stimulation was performed on one sole for 20 minutes.
Group A: With intervention, maximum intensity not reaching pain threshold
Interventions/Control_2
Electrical stimulation was performed on one sole for 20 minutes.
Group B: With intervention, below sensory threshold (sensory threshold x 0.5)
Interventions/Control_3
Group C: No intervention, rest for 20 minutes
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy young adults enrolled in this university who voluntarily agreed to participate in the experiment
Key exclusion criteria
Those with neurological or psychiatric disorders, those with metals or electronic devices such as pacemakers in the body, those taking any medication such as nerve agents, and those with skin disorders.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | MAO |
| Middle name | |
| Last name | TAKEDA |
Organization
Graduate School Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
hpm24015@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | MAO |
| Middle name | |
| Last name | TAKEDA |
Organization
Graduate School Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
hpm24015@nuhw.ac.jp
Sponsor or person
Institute
Graduate School Niigata University of Health and Welfare, Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Niigata University of Health and Welfare Graduate School
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
hpm24015@nuhw.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
| 2025 | Year | 04 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064893
