UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047626 |
|---|---|
| Receipt number | R000054310 |
| Scientific Title | Verification of the Effectiveness of a Corrective Belt for the Foot Inward Bending Orthosis on the Shoe Horn Type Short Leg Orthosis by Normal Subjects. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/04/29 14:46:10 |
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Basic information
Public title
Validation of the Efficacy of the Foot Medial Correction Belt for Short Leg Orthoses by Able-Bodied Patients.
Acronym
Validation of the Efficacy of the Foot Medial Correction Belt for Short Leg Orthotics.
Scientific Title
Verification of the Effectiveness of a Corrective Belt for the Foot Inward Bending Orthosis on the Shoe Horn Type Short Leg Orthosis by Normal Subjects.
Scientific Title:Acronym
Verification of the Corrective Effects of an Internal Belt Added to a Shoe Horn Type Short Leg Orthosis
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to fabricate a shoe horn type with a T-strap for healthy subjects, to perform voluntary ankle joint inversion in the standing posture, and to clarify the difference in corrective force between the shoe horn type and a general shoe horn type.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angle of body section
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two types of orthotic fittings
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
Persons with diseases or injuries of the lower extremities
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimamicho, Kita-ku, Niigata-shi, Niigata
TEL
0252574725
minoru-murayama@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimamicho, Kita-ku, Niigata-shi, Niigata
TEL
0252574725
Homepage URL
minoru-murayama@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare Ethics Committee
Address
1398, Shimamicho, Kita-ku, Niigata-shi, Niigata
Tel
0252574725
minoru-murayama@nuhw.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 | 04 | Month | 01 | 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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054310
