UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054596 |
|---|---|
| Receipt number | R000062358 |
| Scientific Title | Measurement of Foot Orthotics Based on Foot Molding Using Impression Material and Effect Verification Through Gait Analysis |
| Date of disclosure of the study information | 2024/06/08 |
| Last modified on | 2024/06/09 16:54:13 |
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Basic information
Public title
Measurement of Foot Orthotics Based on Foot Molding Using Impression Material and Effect Verification Through Gait Analysis
Acronym
Measurement of Foot Orthotics Based on Foot Molding Using Impression Material and Effect Verification Through Gait Analysis
Scientific Title
Measurement of Foot Orthotics Based on Foot Molding Using Impression Material and Effect Verification Through Gait Analysis
Scientific Title:Acronym
Measurement of Foot Orthotics Based on Foot Molding Using Impression Material and Effect Verification Through Gait Analysis
Region
| Japan |
Condition
Condition
foot disorders
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify how the combination of casting techniques in impression form molding and foot orthotic design affects comfort and foot alignment control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle Inversion/Eversion Angle and VAS (Visual Analog Scale): Evaluation of Orthotic Comfort
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
In this study, the factors and levels considered to influence proprioception through orthotic design are as follows: 1) molding procedure (from the front, from the back), 2) years of experience (less than 3 years, 10 years or more), 3) midfoot compression (light, strong), 4) presence of rearfoot post (yes, no), 5) shell material (soft, hard), and 6) rearfoot control (neutral, valgus). Using these factors, an experimental design employing an orthogonal array will be conducted with one participant to identify the factors with significant main effects and interaction effects. After selecting the factors, a single-subject design using the AB method will be carried out with a small number of cases to scientifically evaluate the effects of these factors.
Interventions/Control_2
Non-orthotic condition
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria: Individuals who provide consent through a consent form.
Key exclusion criteria
Exclusion criteria: Individuals who complain of any foot pain or discomfort, or those who do not provide consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | keisuke |
| Middle name | |
| Last name | kon |
Organization
Hokkaido University of Science
Division name
Department of Orthotics and Prosthetics, Faculty of Health Sciences, Hokkaido University of Science
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-2161
keisukekonn@gmail.com
Public contact
Name of contact person
| 1st name | keisuke |
| Middle name | |
| Last name | kon |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences, Department of Orthotics and Prosthetics
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-2161
Homepage URL
keisukekonn@gmail.com
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science
Address
7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel
011-681-2161
keisukekonn@gmail.com
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
| 2024 | Year | 06 | 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
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
| 2024 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062358
