UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063423 |
|---|---|
| Receipt number | R000072588 |
| Scientific Title | Development of an ankle-foot orthosis using thermoplastic casting tape: orthosis design, basic properties, and a fitting trial in healthy adults |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/26 21:30:15 |
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Basic information
Public title
Development of an Ankle-Foot Orthosis Using Thermoplastic Casting Tape
Acronym
Development of an ankle-foot orthosis using thermoplastic casting tape
Scientific Title
Development of an ankle-foot orthosis using thermoplastic casting tape: orthosis design, basic properties, and a fitting trial in healthy adults
Scientific Title:Acronym
Development study of a thermoplastic casting tape ankle-foot orthosis
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an ankle-foot orthosis using thermoplastic casting tape and to preliminarily evaluate its design, basic properties, fitting, safety, and foot-holding performance in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shank-foot angle
Key secondary outcomes
Secondary outcomes are deformation resistance, fabrication time, orthosis weight, fabrication success rate, visible hazardous areas, fitting suitability, orthosis fitting time, pain, skin problems, neurological or vascular symptoms, orthosis breakage, orthosis displacement, and user-reported evaluation. Deformation resistance will be assessed using a digital force gauge and a digital inclinometer. Fabrication success rate, visible hazardous areas, and fitting suitability will be assessed using checklists. Pain and user-reported evaluation will be assessed using the Numerical Rating Scale.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
| Device,equipment |
Interventions/Control_1
Participants will wear a fabricated ankle-foot orthosis made for each participant using thermoplastic casting tape.
Interventions/Control_2
Participants will wear a commercially available Orthop ankle-foot 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
Foot length of 23.5 to 25.5 cm
Ability to walk independently
Written informed consent to participate in this study
Key exclusion criteria
Individuals with musculoskeletal disorders of the lower limbs
Individuals with skin disease, wounds, or fragile skin of the lower limbs
Individuals with pain, numbness, sensory disturbance, or circulatory disturbance of the lower limbs
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
University of Kawasaki Medical Welfare
Division name
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
kfmbs5599@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
University of Kawasaki Medical Welfare
Division name
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki, Okayama
TEL
06-462-1111
Homepage URL
kfmbs599@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
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
Ethics Committee, Kawasaki University of Medical Welfare
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
Tel
086-462-1111
kfmbs599@mw.kawasaki-m.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
| 2026 | Year | 10 | Month | 27 | 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
| 2026 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072588
