UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057095 |
|---|---|
| Receipt number | R000065257 |
| Scientific Title | Investigation of Intervention Methods Affecting Subjective Walking Speed on a Treadmill |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/05/02 13:51:32 |
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Basic information
Public title
Investigation of Intervention Methods Affecting Subjective Walking Speed on a Treadmill
Acronym
Investigation of Intervention Methods Affecting Subjective Walking Speed on a Treadmill
Scientific Title
Investigation of Intervention Methods Affecting Subjective Walking Speed on a Treadmill
Scientific Title:Acronym
Investigation of Intervention Methods Affecting Subjective Walking Speed on a Treadmill
Region
| Japan |
Condition
Condition
Able-bodied people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish an intervention method to resolve the discrepancy between subjective walking speed on a treadmill and that on level ground. Specifically, we will exploratorily examine the conditions of visual flow presented during treadmill walking, including its type, presentation speed, and size. Additionally, we will investigate changes in subjective walking speed resulting from repeated treadmill walking practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Comfortable Walking Speed During Treadmill Walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In the verification using visual flow, treadmill walking will be performed for approximately 5 to 10 minutes per condition across four conditions, totaling about 20 to 40 minutes. The intervention will be conducted on a single day.
For the examination of the effects of repeated treadmill walking practice, participants will perform 20 minutes of treadmill walking per day for two weeks.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 years or older but under 60 years at the time of consent.
2.Individuals with no history of stroke, neuromuscular disease, or heart disease.
3.Individuals who can walk safely on a treadmill without using handrails.
Key exclusion criteria
1.Individuals with a history of stroke, neuromuscular disease, or heart disease.
2.Individuals who are pregnant or may be pregnant.
3.Individuals deemed unsuitable by the principal investigator or co-investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
tutiyama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Tsuchiyama |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
tutiyama@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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 | 02 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065257
