UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055599 |
|---|---|
| Receipt number | R000063500 |
| Scientific Title | Effects of repeated electrical stimulation on the soles of the foot on dynamic balance function in healthy young people |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2025/09/25 11:40:48 |
* 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
Effects of electrical stimulation on the soles of the feet on human balance function
Acronym
Effects of electrical stimulation on the soles of the feet on human balance function
Scientific Title
Effects of repeated electrical stimulation on the soles of the foot on dynamic balance function in healthy young people
Scientific Title:Acronym
Effects of repeated electrical stimulation on the soles of the foot on dynamic balance function in healthy young people
Region
| Japan |
Condition
Condition
young healthy person
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Balance disorders have been reported as a cause of falls in elderly people. It has been reported that plantar sensation decreases with age, and it has been shown that elderly people with decreased plantar sensation are prone to falls, so the development of an approach focusing on plantar sensation may be important in rehabilitation.
Recently, repetitive electrical stimulation has been reported as a stimulation method to improve sensory function. It has been shown that applying it to the fingers improves sensory and motor function. We hypothesized that applying it to the soles of the feet would change plantar sensation and improve balance function, and examined the effect on static balance function. As a result, it was found that balance function during one-legged standing, which is one of the indicators that can evaluate static balance function, improved. However, the effect on dynamic balance function is unknown. The purpose of this study is to clarify the effect of repetitive electrical stimulation of the soles of the feet on dynamic balance function in young healthy individuals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average velocity of body sway (mm/sec) before, after, and 10 minutes after stimulation obtained by body sway measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Stimulation group (above sensory threshold)
Interventions/Control_2
Stimulation group (below sensory threshold)
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Those with neurological or psychiatric disorders
Those with metal or pacemakers or other electronic devices in their bodies
Those taking nerve-acting medications
Those diagnosed with or suspected of having chronic ankle instability
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MAO |
| Middle name | |
| Last name | TAKEDA |
Organization
Niigata University of Health and Welfare Graduate School
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
Niigata University of Health and Welfare Graduate School
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
Niigata University of Health and Welfare Graduate School
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
| 2024 | Year | 09 | Month | 24 | 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
22
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis and interpretation is taking time.
Additional experiments are being considered.
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063500
