UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061453 |
|---|---|
| Receipt number | R000070319 |
| Scientific Title | Acute effects of perceivable plantar vibration and attentional instruction via a commercial shoe on energy expenditure during treadmill walking: an exploratory randomized crossover study |
| Date of disclosure of the study information | 2026/05/05 |
| Last modified on | 2026/05/05 00:04:20 |
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Basic information
Public title
Acute effects of perceivable plantar vibration and attentional instruction on energy expenditure during walking
Acronym
Vib-PSI EE Study
Scientific Title
Acute effects of perceivable plantar vibration and attentional instruction via a commercial shoe on energy expenditure during treadmill walking: an exploratory randomized crossover study
Scientific Title:Acronym
Vib-PSI EE Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the acute effects of perceivable plantar vibration and attentional instruction directed to plantar sensory input on energy expenditure during treadmill walking in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy expenditure during treadmill walking. Oxygen uptake and carbon dioxide production were measured using a breath by breath system during each 5 minute walking condition, and energy expenditure was calculated. The primary analysis used the period from 180 to 300 seconds.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Vib-Off condition. Participants wore the commercial shoes without perceivable plantar vibration and performed treadmill walking for 5 minutes. This condition served as the reference condition. A 2 minute standing rest interval was provided between conditions.
Interventions/Control_2
Vib-On condition. Participants wore the commercial shoes with perceivable plantar vibration and performed treadmill walking for 5 minutes. A 2 minute standing rest interval was provided between conditions.
Interventions/Control_3
Vib plus PSI condition. Participants wore the commercial shoes with perceivable plantar vibration and received attentional instruction directed to plantar sensory input during treadmill walking for 5 minutes. A 2 minute standing rest interval was provided between conditions.
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
Female
Key inclusion criteria
Healthy women aged 18 to 30 years who were able to walk independently on a treadmill and provided written informed consent to participate in the study.
Key exclusion criteria
Participants with musculoskeletal, neurological, cardiovascular, respiratory, or other medical conditions that could affect treadmill walking or respiratory gas measurements, or those judged by the investigators to be unsuitable for participation, were excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Okoba |
Organization
Prefectural University of Hiroshima
Division name
Course of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan
TEL
0848-60-1120
okoba@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Okoba |
Organization
Prefectural University of Hiroshima
Division name
Course of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan
TEL
0848-60-1120
Homepage URL
okoba@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Aoiro Fabric Co., Ltd.
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
Research Ethics Committee of Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan
Tel
0848-60-1120
okoba@pu-hiroshima.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
| 2026 | Year | 05 | Month | 05 | 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
21
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
Completed
Date of protocol fixation
| 2025 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 05 | Day |
Last modified on
| 2026 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070319
