UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061566 |
|---|---|
| Receipt number | R000070445 |
| Scientific Title | Comparison of the Immediate Effects of Mechanical and Sensory Stimulation to the Plantar Surface on Foot Function and Postural Control Function |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 12:49:24 |
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Basic information
Public title
Comparison of the Immediate Effects of Mechanical and Sensory Stimulation to the Plantar Surface on Foot Function and Postural Control Function
Acronym
Comparison of the Immediate Effects of Mechanical and Sensory Stimulation to the Plantar Surface on Foot Function and Postural Control Function
Scientific Title
Comparison of the Immediate Effects of Mechanical and Sensory Stimulation to the Plantar Surface on Foot Function and Postural Control Function
Scientific Title:Acronym
Comparison of the Immediate Effects of Mechanical and Sensory Stimulation to the Plantar Surface on Foot Function and Postural Control Function
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of a self-care intervention using a massage ball applied to the plantar surface on foot function and postural control function, and to propose safe and practical implementation guidelines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Arch Height Flexibility measured before and immediately after each intervention condition.
Key secondary outcomes
Plantar tactile threshold
Arch Height Index
Center-of-pressure sway parameters during single-leg standing
Peroneus longus muscle activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Low-intensity self-ball condition
Site: Plantar surface
Intensity: 40% to 60% of the pressure pain threshold
Duration: 60 seconds per set, 3 sets
Interventions/Control_2
Low-intensity self-ball condition
Site: Plantar surface
Intensity: 110% to 130% of the pressure pain threshold
Duration: 60 seconds per set, 3 sets
Interventions/Control_3
Sensory stimulation condition
Site: Plantar surface
Intensity: Minimum intensity
Duration: 60 seconds per set, 3 sets
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
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
Individuals who provide informed consent and are able to participate in the study
Individuals identified as right-foot dominant based on the Waterloo Footedness Questionnaire
Key exclusion criteria
Individuals with a history of lower limb injury or surgery within the past year
Individuals with pain in the right lower limb
Individuals with skin abnormalities at the intervention site
Individuals with neurological or musculoskeletal disorders
Individuals who engage in regular exercise three or more times per week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Nakayama |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hpm25013@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Nakayama |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hpm25013@nuhw.ac.jp
Sponsor or person
Institute
Graduate School, Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Graduate School, Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
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
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
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
| 2026 | Year | 05 | Month | 14 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070445
