UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057530 |
|---|---|
| Receipt number | R000065723 |
| Scientific Title | Effects of Different Footpad Placements on Postural Sway During Single-Leg Stance |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2026/04/12 18:22:04 |
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Basic information
Public title
Effect of foot sole stimulation on single-leg balance test
Acronym
Foot sole stimulation and single-leg stance
Scientific Title
Effects of Different Footpad Placements on Postural Sway During Single-Leg Stance
Scientific Title:Acronym
Effect of Foot Pad on Postural Sway
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of applying 2-mm-thick footpads to different plantar locations on postural sway during single-leg stance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects will be measured the center of pressure during single-leg stance under each condition.
Five conditions were established. Control Group, Medial pad Group, Lateral Pad Group, Metatarsal Head Pad Group, Full Pad Group .
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The participant stood in a relaxed posture on the balance function measuring device before assuming a single-leg stance on the chosen supporting leg following the examiner's instructions.
The non-supporting leg was instructed to be flexed at the hip and knee to 90 degree.
The arms were crossed in front of the chest. Participants were instructed to focus on a marker placed 3 m ahead at eye level and maintain their single-leg stance as steadily as possible.
The single-leg stance is performed for 40seconds, 3times for each condition. A 2-minute rest is allowed between sessions.
Interventions/Control_2
Since the initial 10 seconds of measurement involve greater postural sway, COP measurement was taken for 30 seconds after the first 10 seconds.
Interventions/Control_3
The conditions will be as follows:
Control group, no pad attached
Medial pad group, the pad was attached perpendicularly below the navicular tuberosity
Lateral pad group, the pad was placed to avoid contact with the fifth metatarsal head
Metatarsal Head pad group, the examiner passively extended the interphalangeal joints of the second, third, and fourth toes to ensure the pad did not contact the metatarsal heads
Full pad group, included all pad placements from the Medial pad, Lateral pad, and Metatarsal Head pad groups
Interventions/Control_4
A 2-mm-thick rubber sheet (Shore hardness 50) was used for pad interventions
The pad sizes were 30 x 15 mm for the Medial and Lateral groups and an equilateral triangle with a side length of 30 mm for the Metatarsal Head group.
Interventions/Control_5
Five group
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult males (undergraduate students) who have been informed of the purpose and methods of the study and who have given written consent.
Key exclusion criteria
Individuals with a history of neuromuscular diseases.
Individuals with history of lower limb injuries such as ankle sprains.
Individuals with a history of lower limb surgery.
Individuals with plantar sensory impairment.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Takata |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
061-1449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340109
takata@do-bunkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Maruoka |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
061-1449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340219
Homepage URL
h.maruoka.0105@gmail.com
Sponsor or person
Institute
Hokkaido Bunkyo University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Bunkyo University
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
Hokkaido Bunkyo University
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
Tel
0123340109
takata@do-bunkyodai.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 | 18 | Day |
Related information
URL releasing protocol
https://figshare.com/articles/dataset/Single_Leg_Stance_COP_data_xlsx/28720889?file=53431619
Publication of results
Unpublished
Result
URL related to results and publications
https://figshare.com/articles/dataset/Single_Leg_Stance_COP_data_xlsx/28720889?file=53431619
Number of participants that the trial has enrolled
21
Results
Among the four COP parameters analyzed, three parameters total path length, medial-lateral sway velocity, and anterior-posterior sway velocity showed significant differences in a repeated measures one-way ANOVA (p<0.01). However, ellipse area showed no significant difference (p>0.05).
Post-hoc Bonferroni analysis indicated that the COP parameter was significantly reduced in the intervention groups compared to the control group.
Results date posted
| 2025 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
21 healthy adults participated.
Participant flow
Prior to participation, all subjects received a thorough explanation of the study's purpose and methods and provided informed consent.
Adverse events
No adverse events occurred.
Outcome measures
center of pressure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 05 | 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 | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065723
