UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051038 |
|---|---|
| Receipt number | R000058031 |
| Scientific Title | Effect of Electrical Stimulation of the Plantar Foot on One-Leg Standing Balance |
| Date of disclosure of the study information | 2023/05/11 |
| Last modified on | 2023/05/11 15:50:39 |
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Basic information
Public title
Effect of Electrical Stimulation of the Plantar Foot on One-Leg Standing Balance
Acronym
Effect of Electrical Stimulation of the Plantar Foot on One-Leg Standing Balance
Scientific Title
Effect of Electrical Stimulation of the Plantar Foot on One-Leg Standing Balance
Scientific Title:Acronym
Effect of Electrical Stimulation of the Plantar Foot on One-Leg Standing Balance
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of electrical stimulation to the plantar feet on one-leg standing balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of pressure sway (total sway path length, mean sway velocity, and area) during one-leg standing before and after stimulus intervention.
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation of the sole of the foot for 20 minutes (1.8 times the sensory threshold)
Interventions/Control_2
Electrical stimulation of the plantar foot for 20 minutes (0.5 times the 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
The subjects were healthy men and women with no exercise habits who were interested in the study and voluntarily volunteered to participate in the study.
Key exclusion criteria
The subjects with orthopedic or neurological disease.
The subjects who are unable to hold a one-legged standing position for 30 seconds.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuto |
| Middle name | |
| Last name | Inukai |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4310
inukai@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yasuto |
| Middle name | |
| Last name | Inukai |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4310
Homepage URL
inukai@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4455
rinri@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
| 2023 | Year | 05 | Month | 11 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058031
