UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058910 |
|---|---|
| Receipt number | R000067372 |
| Scientific Title | Subjective evaluation of the comfortability and functionality of the ankle orthosis. |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/29 19:38:08 |
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Basic information
Public title
Subjective evaluation of the comfortability and functionality of the ankle orthosis.
Acronym
Subjective evaluation of the comfortability and functionality of the ankle orthosis.
Scientific Title
Subjective evaluation of the comfortability and functionality of the ankle orthosis.
Scientific Title:Acronym
Subjective evaluation of the comfortability and functionality of the ankle orthosis.
Region
| Japan |
Condition
Condition
None specified
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the comfort and functionality of a newly developed ankle orthosis compared with a conventional orthosis based on users' subjective evaluations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective comfort and functionality of ankle orthosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
New-type ankle orthosis
Interventions/Control_2
Conventional-type ankle orthosis
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Engages in sports activities at least twice a week.
2) Written consent for research participation has been obtained from the individual.
Key exclusion criteria
1) The patient has a skin condition around the ankle joint or may develop skin damage due to wearing an orthotic device.
2) The patient is currently undergoing treatment for an injury or disease around the ankle joint.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Imade |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Orthopaedic Surgery
Zip code
6939801
Address
89-1, Enya, Izumo, Shimane
TEL
81853202242
imades@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Imade |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Orthopaedic Surgery
Zip code
6938501
Address
89-1, Enya, Izumo, Shimane
TEL
81530202242
Homepage URL
imades@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Shinji Imade
Funding Source
Organization
Oda City, Shimane Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1, Enya, Izumo, Shimane
Tel
81853202515
kenkyu@med.shimane-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
| 2025 | Year | 08 | Month | 29 | 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
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067372
