UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057609 |
|---|---|
| Receipt number | R000065822 |
| Scientific Title | Observational Study of Motor and Behavioral Changes in Different Corrective Clothing |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/04/14 20:48:46 |
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Basic information
Public title
Observational Study of Motor and Behavioral Changes in Different Corrective Clothing
Acronym
Observational Study of Motor and Behavioral Changes in Different Corrective Clothing
Scientific Title
Observational Study of Motor and Behavioral Changes in Different Corrective Clothing
Scientific Title:Acronym
Observational Study of Motor and Behavioral Changes in Different Corrective Clothing
Region
| Japan |
Condition
Condition
Orthopedics
Classification by specialty
| Orthopedics | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in locomotor function due to the wearing of corrective clothing (leggings) in women in their 40s and older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Joint angles of each joint measured by motion capture
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Using Type A correction wear (leggings) with a support function that makes it easier to raise the legs when walking, the angle of each joint when wearing the correction wear (leggings), the feeling of wearing the correction wear (leggings), and the amount of activity while wearing the correction wear (leggings) will be evaluated.
Interventions/Control_2
The correction garment (leggings) is Type B, which does not have a support function that makes it easier to raise the legs when walking. The angle of each joint when wearing the correction garment (leggings), the feeling of wearing the correction garment (leggings), and the amount of activity while wearing the correction garment (leggings) are evaluated.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
(i) Age: 40 years old or older at the time of obtaining consent.
2) Gender: Female
(iii) No symptoms of physical pain (iv) Able to walk independently
(iv) Able to walk on their own
(v) Subjects who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the subject's wishes.
Key exclusion criteria
(i) Pregnant women and those who may be pregnant or nursing, and those who wish to become pregnant during the research period.
(ii) Others whom the project leader determines to be inappropriate as research subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Yotsuya |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-3111
jyotsuya@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Okamoto |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-3111
Homepage URL
tokamoto@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
e-GATE
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
Tel
0776-61-3111
rinsho-rinri@ml.u-fukui.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 | 04 | Month | 14 | 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
20
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
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065822
