UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047505 |
|---|---|
| Receipt number | R000054176 |
| Scientific Title | About the effect of hallux extension dynamic orthotic device on attitude control. |
| Date of disclosure of the study information | 2022/04/17 |
| Last modified on | 2022/04/16 22:17:34 |
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Basic information
Public title
About the effect of hallux extension dynamic orthotic device on attitude control.
Acronym
About the effect of hallux extension dynamic orthotic device on attitude control.
Scientific Title
About the effect of hallux extension dynamic orthotic device on attitude control.
Scientific Title:Acronym
About the effect of hallux extension dynamic orthotic device on attitude control.
Region
| Japan |
Condition
Condition
Healthy woman
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of wearing a hallux dynamic extension device on postural control using kinematic, kinematic and physiological methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Physical exercise data in static standing and disturbed standing
2. Physical exercise data in the movement to start walking
3. Physical exercise data with continuous wearing for a certain period of time
4. Immediateness of reaction by wearing hallux orthotic device
5. Sustainability of reaction by wearing hallux orthotic device
Key secondary outcomes
1. Adverse events when wearing hallux orthotics
2.EMG data when wearing a hallux orthotic device
3. Relationship with basic physical function
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hallux extension traction device with foot orthotic device.
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
| 19 | years-old | <= |
Age-upper limit
| 77 | years-old | >= |
Gender
Female
Key inclusion criteria
1. The subjects of the study are healthy women, both young and old.
2. Those who do not have musculoskeletal disorders and, in principle, have not undergone orthopedic surgery in the past year.
Key exclusion criteria
We decided to exclude those who have the following conditions that may affect the results of attitude control experiments.
1. Those who have difficulty in understanding verbal instructions and have low communication
2. Persons with internal medicine / circulatory system diseases, etc., who are judged to have low responsiveness to continuous measurement
3. Those who have surgical procedures or joint deformities with changes in anatomical structure
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Saito |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
TEL
075-571-1111
Saito-K@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Saito |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
TEL
075-571-1111
Homepage URL
saito-k@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Tachibana University
Address
34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
Tel
075-571-1111
saito-k@tachibana-u.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
| 2022 | Year | 04 | Month | 17 | 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
51
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 04 | Month | 16 | Day |
Last modified on
| 2022 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054176
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| Registered date | File name |
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| Registered date | File name |
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