UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051710 |
|---|---|
| Receipt number | R000059019 |
| Scientific Title | Effects of insole therapy on physical function |
| Date of disclosure of the study information | 2023/07/25 |
| Last modified on | 2025/07/27 12:51:14 |
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Basic information
Public title
Effects of wearing insole on human movement
Acronym
Effect of insole
Scientific Title
Effects of insole therapy on physical function
Scientific Title:Acronym
Effect of insole
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on posture and physical function depending on the with or without insole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion using biomechanical analysis
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
medial arch support
Interventions/Control_2
lateral heel wedge
Interventions/Control_3
medial heel wedge
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 and Female
Key inclusion criteria
Those who can do basic physical exercise
Key exclusion criteria
Those who have difficulty in basic physical exercise
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University
Division name
School of Allied Health Science
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8407
hw@ahs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University
Division name
School of Allied Health Science
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8407
Homepage URL
hw@ahs.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Kitasato University ethics commitee
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8894
inouek@kitasato-u.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 | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To increase the statistical power of this study, we decided to recruit additional clinical trials.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Two medical institutions will open a call for applications, and subjects who meet the eligibility criteria and desired measurement conditions will be introduced into the measurement protocol.
Adverse events
Outcome measures
The study used three-dimensional motion analysis and inertial sensors. The main outcome was the abduction moment of the lower leg.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059019
