UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053474 |
|---|---|
| Receipt number | R000061007 |
| Scientific Title | Effect of novel therapeutic exercise for the alignment and kinematics flatfoot deformity |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/01/30 09:49:19 |
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Basic information
Public title
Effect of novel therapeutic exercise for the alignment and kinematics flatfoot deformity
Acronym
Effect of novel therapeutic exercise for the flatfoot deformity
Scientific Title
Effect of novel therapeutic exercise for the alignment and kinematics flatfoot deformity
Scientific Title:Acronym
Effect of novel therapeutic exercise for the flatfoot deformity
Region
| Japan |
Condition
Condition
flatfoot
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
clarified effects of novel therapeutic exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
foot alignment, foot kinematics during gait and running
Key secondary outcomes
plantar foot distribution, plantar foot sensory, muscle structure of the intrinsic foot muscle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
short foot exercise
Interventions/Control_2
Arch raise exercise
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Foot posture index >6
did not have any pain in the body, and did not have any medical history in the lower limb.
Key exclusion criteria
subject who had any nerophysiological disease and surgical approach
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya university of medical sciences
Division name
Inclusive medical sciences research institute
Zip code
559-8611
Address
Nanko-kita 1-26-16 Suminoe ward, Osaka city, Osaka, Japan
TEL
0666166917
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya university of medical sciences
Division name
Inclusive medical sciences research institute
Zip code
559-8611
Address
Nanko-kita 1-26-16, Suminoe ward, Osaka city, Osaka, Japan
TEL
0666166917
Homepage URL
kudo@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical sciences
Institute
Department
Personal name
Shintarou Kudo
Funding Source
Organization
Morinomiya univeristy of medical sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Morinomiya university of medical sciences
Address
Nanko-kita1-26-16, Suminoe ward, Osaka city, Osaka, Japan
Tel
06-6616-6911
kenkyu@morinomiya-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
| 2024 | Year | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
