UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061708 |
|---|---|
| Receipt number | R000070616 |
| Scientific Title | Effects of Forefoot Design of Ankle-Foot Orthoses on Gait Mechanics: A Pilot Study |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/27 17:50:25 |
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Basic information
Public title
Pilot study investigating the effects of forefoot design of ankle-foot orthoses on gait
Acronym
Forefoot AFO Pilot Study
Scientific Title
Effects of Forefoot Design of Ankle-Foot Orthoses on Gait Mechanics: A Pilot Study
Scientific Title:Acronym
Forefoot AFO Pilot Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory pilot study aims to investigate the effects of different forefoot designs of ankle-foot orthoses (AFOs) on gait mechanics in healthy adults. As a preliminary investigation for future studies involving children with cerebral palsy, gait characteristics during walking with a forefoot-cut AFO and a rigid forefoot AFO will be compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum extension angle of the first metatarsophalangeal joint (MTP1 joint)
Key secondary outcomes
Propulsive impulse, soleus muscle activity, peak electromyographic activity during gait (EMG peak), MVC-normalized muscle activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait assessment will be performed under the barefoot condition.
Interventions/Control_2
Gait assessment will be performed while wearing a forefoot-cut ankle-foot orthosis (AFO).
Interventions/Control_3
Gait assessment will be performed while wearing a rigid forefoot ankle-foot orthosis (AFO).
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Individuals who provided informed consent for study participation
Healthy male adults aged 18 to 30 years
Individuals compatible with the orthosis size (foot length: 26.5 cm)
Key exclusion criteria
Individuals with gait impairment
Individuals for whom surface electromyography electrode placement is difficult due to skin disorders or related conditions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Seijoh University
Division name
Research Student
Zip code
4768588
Address
Fukinodai, Tokai City, Aichi 476-8588, Japan
TEL
07085772390
suutan.19o9o695@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Seijoh University
Division name
Research Student
Zip code
4768588
Address
Fukinodai, Tokai City, Aichi 476-8588, Japan
TEL
07085772390
Homepage URL
suutan.19o9o695@gmail.com
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee of Seijoh University
Address
Fukinodai, Tokai City, Aichi 476-8588, Japan
Tel
07085772390
suutan.19o9o695@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
| 2026 | Year | 05 | Month | 28 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070616
