UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050271 |
|---|---|
| Receipt number | R000054142 |
| Scientific Title | Relationship of visual, vestibular and somatosensory perception to body sway after treadmill walking |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2023/02/08 14:18:19 |
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Basic information
Public title
Relationship of visual, vestibular and somatosensory perception to body sway after treadmill walking
Acronym
Relationship of visual, vestibular and somatosensory perception to body sway after treadmill walking
Scientific Title
Relationship of visual, vestibular and somatosensory perception to body sway after treadmill walking
Scientific Title:Acronym
Relationship of visual, vestibular and somatosensory perception to body sway after treadmill walking
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between body sway and visual, vestibular and somatosensory perception during sensory conflict after treadmill walking.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of center of foot pressure sway tests before and after treadmill walking
Key secondary outcomes
Evaluation of plantar sensation, vestibulo-ocular reflex, and motion sickness during visual stimulation before center-of-foot pressure sway test.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
6 minutes treadmill walking
Interventions/Control_2
6 minutes overground walking
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults who can express informed consent by documents.
Key exclusion criteria
No history of neurological or psychiatric disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Oka |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, School of Rehabilitation
Zip code
811-0213
Address
2-1-12, Wajiro, Higashiku, Fukuoka City, Fukuoka, Japan
TEL
092-607-6701
s.oka@kyoju.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Oka |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12, Wajiro, Higashiku, Fukuoka City, Fukuoka, Japan
TEL
092-687-8700
Homepage URL
s.oka@kyoju.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Shinichiro Oka
Funding Source
Organization
grants JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare,Institutional Review Board
Address
137-1 Enokizu, Okawa-shi, Fukuoka
Tel
0944-89-2000
s.oka@kyoju.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
| 2023 | Year | 02 | Month | 08 | 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
13
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054142
