UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061330 |
|---|---|
| Receipt number | R000070126 |
| Scientific Title | The Relationship Between Ankle Function and Brain Structure and Neural Networks |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/21 11:34:47 |
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Basic information
Public title
The Relationship Between Ankle Function and Brain Structure and Neural Networks
Acronym
The Relationship Between Ankle Function and Brain Structure and Neural Networks
Scientific Title
The Relationship Between Ankle Function and Brain Structure and Neural Networks
Scientific Title:Acronym
The Relationship Between Ankle Function and Brain Structure and Neural Networks
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between ankle joint function and brain structure and neural networks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First, head MRI images of the subjects are acquired. Next, visual tracking and joint position sense tasks are performed to assess ankle joint function. The interval between the head MRI scan and the performance of each task should be within one week. Brain imaging data is acquired using a 32-channel head coil (QD coil, 32-channel Head SPEEDER Coil) and a 3T Vantage Galan MRI scanner (Canon Medical Systems, Tochigi, Japan). The acquired images include T1-weighted images, T2-weighted images, and resting-state functional images.
Key secondary outcomes
In the visual tracking task, we used waveform offset detection software (S-17526, Takei Kiki Kogyo) and an AD converter (TSA-210, Takei Kiki Kogyo) to record the plantar flexion and dorsiflexion angles of the right ankle at a sampling frequency of 100 Hz. We instructed the subjects to track the target waveform on the monitor by voluntarily adjusting the ankle angle. Defining 10 degrees plantar flexion as 0% and 20 degrees dorsiflexion as 100%, sinusoidal waveforms combining three angle ranges (0-60%, 0-70%, 0-80%) and two duration settings (2.5 seconds, 5 seconds) were presented randomly. The task consisted of three trials, each lasting 60 seconds.
For the joint position sense task, we used the PowerLab signal analysis system (AD Instruments) and LabChart 8 (AD Instruments) to record the dorsiflexion and plantarflexion angles of the right ankle at a sampling frequency of 4000 Hz. The subject was instructed to reproduce the passively presented right ankle angle through active movement; the presented angles were set to three conditions (ankle in plantar flexion at approximately 0 degrees, 10 degrees dorsiflexion, and 20 degrees dorsiflexion). A total of 15 trials were conducted in random order, with five trials for each angle.
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
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We will use the university's internal email system to notify undergraduate and graduate students of the call for research participants. We will accept as research participants only those students who express an interest in this study and have fully understood its content, and who voluntarily agree to participate in the experiment of their own free will. The eligibility criteria require participants to be between 18 and 27 years of age.
Key exclusion criteria
Participants with implanted metal devices (such as pacemakers), those with claustrophobia, and those with a history of ankle injuries will be excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Graduate School of Health and Welfare Sciences, Department of Health Sciences, Division of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
0252574455
hpm26005@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Graduate School of Health and Welfare Sciences, Department of Health Sciences, Division of Physical
Zip code
9503198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
0252574455
Homepage URL
hpm26005@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
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
Ethics Review Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
Tel
0252574455
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 | 04 | Month | 22 | 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 | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will use the university's internal email system to notify undergraduate and graduate students of the call for research participants. We will accept as research participants only those students who express an interest in this study and have fully understood its content, and who voluntarily agree to participate in the experiment of their own free will. The experimental protocol begins with the acquisition of head MRI images. Subsequently, to assess ankle joint function, we will conduct a visual tracking task and a joint position sense task. The interval between the head MRI scan and the performance of each task will be within one week. Brain imaging data will be acquired using a 32-channel head coil (QD coil, 32-channel Head SPEEDER Coil) and a 3T Vantage Galan MRI scanner (Canon Medical Systems, Tochigi, Japan). The images acquired will include T1-weighted images, T2-weighted images, and resting-state functional images.
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070126
