UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063531 |
|---|---|
| Receipt number | R000072706 |
| Scientific Title | A Study on the Effects of Frictional Moments on Gait Stability under Controlled Friction within the Plantar Contact Area |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/05 16:59:07 |
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Basic information
Public title
A Study on the Effects of Frictional Moments on Gait Stability under Controlled Friction within the Plantar Contact Area
Acronym
A Study on the Effects of Frictional Moments on Gait Stability under Controlled Friction within the Plantar Contact Area
Scientific Title
A Study on the Effects of Frictional Moments on Gait Stability under Controlled Friction within the Plantar Contact Area
Scientific Title:Acronym
A Study on the Effects of Frictional Moments on Gait Stability under Controlled Friction within the Plantar Contact Area
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To determine how different floor friction conditions affect the frictional moment (free moment: FM) generated within the plantar contact area during walking.
2. To determine how differences in shoe sole contact geometry affect the magnitude of FM and foot rotational motion.
3. To clarify the relationships between FM and joint angles, joint moments, and whole-body angular momentum (WBAM), and to examine whether FM can serve as an indicator of rotational constraints at the foot-ground interface.
Basic objectives2
Others
Basic objectives -Others
To determine how differences in floor friction conditions affect the frictional moment (free moment: FM) generated within the plantar contact area during walking, and how differences in shoe sole contact geometry affect the magnitude of FM and foot rotational motion. Furthermore, to analyze the relationships between FM and joint angles, joint moments, and whole-body angular momentum (WBAM), and to examine whether FM can serve as an indicator of rotational constraints at the foot-ground interface.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The maximum absolute value of the frictional moment about the vertical axis at the foot-ground interface (free moment: FM) during the stance phase of walking, compared across different floor friction conditions and shoe sole contact geometries.
Key secondary outcomes
The FM waveform and time integral of its absolute value during the stance phase of walking; foot rotation angle, rotational range of motion, and rotational angular velocity; lower-limb joint angles and moments; whole-body angular momentum; and gait stability measures (margin of stability, step width variability, and gait cycle duration variability). Differences between conditions and associations with FM will be evaluated for each measure.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who provide written informed consent to participate in the study.
(2) Individuals aged 18-39 years.
(3) Individuals who can walk independently without assistive devices in daily life.
(4) Individuals who can safely and independently perform straight-line walking both overground and on a treadmill.
(5) Individuals who can understand the study procedures and follow the experimenter's instructions.
(6) Individuals deemed suitable for participation by the principal investigator or a co-investigator.
Key exclusion criteria
(1) Individuals with neurological, musculoskeletal, or other conditions that affect walking.
(2) Individuals with pain or injuries that affect walking.
(3) Individuals for whom walking tests are difficult to perform due to severe cardiovascular disease or other serious medical conditions.
(4) Individuals otherwise deemed unsuitable for participation by the principal investigator or other study investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University
Division name
Graduate School of Engineering
Zip code
980-8579
Address
Aramaki-aza-aoba 6-6-01, Sendai, Miyagi
TEL
0227956897
takeshi.yamaguchi.c8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University
Division name
Graduate School of Engineering
Zip code
9808579
Address
Aramaki-aza-aoba 6-6-01, Sendai, Miyagi
TEL
0227956897
Homepage URL
takeshi.yamaguchi.c8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Research Ethics Committee, Tohoku University
Address
2-1-1, Katahira, Aoba-ku, Sendai, Miyagi, Japan
Tel
N/A
tuhrp-soudan1@grp.tohoku.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 | 11 | Month | 13 | 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
| 2006 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will assess walking under different floor friction conditions and shoe sole contact geometries. Measurements will include the frictional moment about the vertical axis at the foot-ground interface (free moment: FM), foot rotational motion, lower-limb joint angles and moments, whole-body angular momentum, and gait stability measures. Comparisons across conditions and analyses of associations with FM will be conducted to examine whether FM can serve as an indicator of rotational constraints at the foot-ground interface and gait stability.
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072706
