UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063216 |
|---|---|
| Receipt number | R000072351 |
| Scientific Title | Changes in indicators of slip- and trip-related fall risk during walking in relation to aging, cognitive load, and cognitive fatigue |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/08 12:04:23 |
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Basic information
Public title
Changes in indicators of slip- and trip-related fall risk during walking in relation to aging, cognitive load, and cognitive fatigue
Acronym
Changes in indicators of slip- and trip-related fall risk during walking in relation to aging, cognitive load, and cognitive fatigue
Scientific Title
Changes in indicators of slip- and trip-related fall risk during walking in relation to aging, cognitive load, and cognitive fatigue
Scientific Title:Acronym
Changes in indicators of slip- and trip-related fall risk during walking in relation to aging, cognitive load, and cognitive fatigue
Region
| Japan |
Condition
Condition
Health adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the effects of cognitive load and cognitive fatigue on the required coefficient of friction, minimum toe clearance, and spatiotemporal gait parameters during straight walking and turning in healthy young and older adults, and to examine how aging, cognitive load, and cognitive fatigue affect indicators of slip- and trip-related fall risk during walking.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the effects of aging, cognitive load, and cognitive fatigue on gait indicators related to slip- and trip-induced falls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Required coefficient of friction (RCOF)
Minimum toe clearance (MTC)
Key secondary outcomes
Mean values and coefficients of variation of step length, walking speed, step width, double-support duration, and single-support duration
Performance on the serial subtraction task and the psychomotor vigilance task (PVT)
PVT performance and visual analogue scale (VAS) scores before and after the cognitive fatigue induction task
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have received an explanation of the study and provided written informed consent to participate.
Young adults aged 18-39 years or older adults aged 60 years or above.
Individuals who can walk independently in daily life without using walking aids such as a cane.
Individuals who can independently and safely perform the straight walking, step turns, and spin turns required in this study.
Individuals who can understand the study procedures and the experimenter's instructions and perform the serial subtraction-by-seven task and the Psychomotor Vigilance Task.
Individuals deemed eligible to participate in this study by the principal investigator or a co-investigator.
Key exclusion criteria
Individuals with neurological or musculoskeletal diseases or other conditions that affect walking.
Individuals with pain or injuries that affect walking.
Individuals who have difficulty safely performing the walking tests due to severe cardiovascular diseases or other conditions.
Individuals who have difficulty performing the study tasks due to visual or hearing impairments or other conditions.
Individuals who have difficulty understanding the study procedures or performing the cognitive tasks due to cognitive impairment.
Individuals otherwise deemed unsuitable for participation in this study by the principal investigator or a co-investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University
Division name
Finemechanics department, Graduate School of Engineering
Zip code
98008579
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
Finemechanics department, Graduate School of Engineering
Zip code
98008579
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
National Institute of Occupational Safety and Health, Japan
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 | 10 | 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
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine newly collected gait data from healthy young and older adults. The required coefficient of friction, minimum toe clearance, and spatiotemporal gait parameters will be measured during straight walking and turning. These measures will be compared between age groups, with and without cognitive load, and before and after cognitive fatigue to examine the relationships of these factors with indicators of slip- and trip-related fall risk during walking.
Management information
Registered date
| 2026 | Year | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072351
