UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061591 |
|---|---|
| Receipt number | R000070470 |
| Scientific Title | Investigation of the Optimal Apex Position of Rocker Soles for Improving Gait in Patients with Ankle Joint Immobilization |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/15 19:27:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the Optimal Apex Position of Rocker Soles for Improving Gait in Patients with Ankle Joint Immobilization
Acronym
Investigation of the Optimal Apex Position of Rocker Soles for Improving Gait in Patients with Ankle Joint Immobilization
Scientific Title
Investigation of the Optimal Apex Position of Rocker Soles for Improving Gait in Patients with Ankle Joint Immobilization
Scientific Title:Acronym
Investigation of the Optimal Apex Position of Rocker Soles for Improving Gait in Patients with Ankle Joint Immobilization
Region
| Japan |
Condition
Condition
patients with ankle joint immobilization
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine and propose the optimal ankle rocker shape during the mid-stance to terminal stance phases of gait for patients with ankle immobilization in order to improve gait performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative and evaluative analyses of gait data obtained from three-dimensional motion analysis, including kinematic and kinetic measurements, will be conducted, alongside subjective evaluations by the study participants.
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
| Other |
Interventions/Control_1
Modification of the rocker sole shape of footwear
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy participants without musculoskeletal disorders affecting either lower limb
Key exclusion criteria
Individuals with any orthopedic disorder affecting the lower extremities
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Hayakawa |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
4-1, 7-jo 15-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
0116882409
yasuyuki@hus.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Hayakawa |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
0630826
Address
4-1, 7-jo 15-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
09039619924
Homepage URL
hayakawayasuyuki7@gmail.com
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Yasuyuki Hayakawa
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
4-1, 7-jo 15-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel
0116882409
yasuyuki@hus.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070470
