UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060790 |
|---|---|
| Receipt number | R000069548 |
| Scientific Title | Neurophysiological basis of gait initiation characterstics in aging |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/01 23:06:52 |
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Basic information
Public title
Examination of gait initiation
Acronym
Aging and gait initiation
Scientific Title
Neurophysiological basis of gait initiation characterstics in aging
Scientific Title:Acronym
Aging gait initiation-Neurophysiology
Region
| Japan |
Condition
Condition
Healthy young adults and Healthy older adults
Classification by specialty
| Neurology | Rehabilitation medicine | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of age-related neurophysiological changes on gait initiation characteristics
Basic objectives2
Others
Basic objectives -Others
To contribute to fall prevention and oriented rehabilitation interventions by clarifying age-related characteristics of gait initiation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Beta band 13-30 Hz EEG EMG corticomuscular coherence between motor cortex and tibialis anterior during gait initiation at baseline single session assessment
Key secondary outcomes
Beta band 13-30 Hz EEG EMG corticomuscular coherence during steady state walking at baseline single session assessment
Anticipatory postural adjustment APA parameters during gait initiation including posterior center of pressure displacement APA duration and center of pressure peak latency
Kinematic parameters during gait initiation including initial step length initial step time gait initiation velocity and lower limb joint angle excursion
Spatiotemporal parameters during steady state walking including gait speed step length gait cycle duration and coefficient of variation of step length
Muscle activation amplitude RMS and onset latency of lower limb muscles
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy young adults aged 20 to 40 years and healthy older adults aged 65 years or older who are able to walk independently. Participants must be able to understand the study procedures and provide written informed consent. Participants must be able to perform repeated 10 m walking trials with rest as needed.
Key exclusion criteria
History of stroke, Parkinson disease, spinal cord disease, peripheral neuropathy, uncontrolled epilepsy, progressive dementia, severe depression, or schizophrenia diagnosed by a physician.
Surgery or fracture within the past 3 months, marked limitation of joint range of motion, or severe osteoarthritis.
Resting systolic blood pressure 180 mmHg or higher, diastolic blood pressure 110 mmHg or higher, NYHA class III or higher heart failure, myocardial infarction within the past 6 months, unstable angina, syncope, or severe dyspnea.
Mini Mental State Examination score of 23 or lower.
Inability to perform repeated 10 m walking trials even with rest periods, or use of a wheeled walker.
Skin disease, wound, severe tape allergy, or metal allergy at electrode attachment sites.
Determined to have a high risk of falling during the practice session by consensus of two assessors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hamauchi |
| Middle name | |
| Last name | Koichi |
Organization
Graduate School of Kio University
Division name
Division of Rehabilitation Sciences, Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-23 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832
TEL
0906800187
hg812743@gmail.com
Public contact
Name of contact person
| 1st name | Hamauchi |
| Middle name | |
| Last name | Koichi |
Organization
Graduate School of Kio University
Division name
Division of Rehabilitation Sciences, Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-23 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832
TEL
09068001874
Homepage URL
hg812743@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Master's Program in Health Sciences, Division of Rehabilitation Sciences, Graduate School of Health Sciences, Kio University
Address
4-2-23 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832
Tel
090
hg812743@gmail.com
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 | 03 | Month | 02 | 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 | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study with no therapeutic intervention. As an assessment task, participants start walking from quiet standing on a force plate and walk along a 7 m straight walkway at a comfortable speed. Ten out and back walks per set are performed with a total of 100 trials, while EEG, surface EMG from 16 lower limb muscles, 8 inertial sensors, and ground reaction forces are recorded simultaneously.
Management information
Registered date
| 2026 | Year | 03 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069548
