UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061367 |
|---|---|
| Receipt number | R000070216 |
| Scientific Title | Effects of the Medial Longitudinal Arch Support on Dynamic Knee Valgus during Single Leg Drop Cutting in Females with overpronated feet: a cross over study |
| Date of disclosure of the study information | 2026/04/24 |
| Last modified on | 2026/04/24 13:25:20 |
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Basic information
Public title
The Effect of the Insole for Knee movement during Cutting in Females with Flat feet
Acronym
Effect of Insole for Knee movement in Females with flat feet
Scientific Title
Effects of the Medial Longitudinal Arch Support on Dynamic Knee Valgus during Single Leg Drop Cutting in Females with overpronated feet: a cross over study
Scientific Title:Acronym
Insole and knee valgus in females with pronated feet
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a medial longitudinal arch-support insole on dynamic knee valgus during single-leg squats and single-leg drop cutting in females with an overpronated foot.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knee valgus angles at initial contact and at peak vertical ground reaction force during single-leg drop cutting
Key secondary outcomes
maximum knee valgus angle and moment during single-leg squat, knee valgus moment at initial contact and at peak vertical ground reaction force during single-leg drop cutting
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
use of insole
Interventions/Control_2
Control
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Females who have an overpronated foot on their dominant leg (normalized truncated navicular height <0.21)
Key exclusion criteria
Participants with a history of surgery or pain in the lower limbs or lumbar region on the day of measurement
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Mori |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
Ochanomizu Center Building, 3-2-12, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111(3940)
k.mori.uo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Mori |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
Ochanomizu Center Building, 3-2-12, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111(3940)
Homepage URL
k.mori.uo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Kana Mori
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
Ethics Committee of the Faculty of Health Science, Juntendo University
Address
3rd Floor, Radiological Technology Training Building, Juntendo University, 1-5-31, Yushima, Bunkyo-ku, Tokyo, 113-0033
Tel
03-5802-1208
grad.hs@juntendo.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
順天堂大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
This study protocol is not available to the public.
Publication of results
Published
Result
URL related to results and publications
This study protocol is not available to the public.
Number of participants that the trial has enrolled
19
Results
The knee valgus angle at IC during single-leg drop cutting was significantly smaller with the insole than without it (p = 0.048).
No significant differences were observed between without and with the insole for knee valgus angle during single-leg squat and at peak vertical ground reaction force during single-leg drop cutting.
No significant differences were observed in the knee valgus moment between the insole conditions at either time point during single-leg drop cutting.
Results date posted
| 2026 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the participants was 21.0 years, the median Tegner activity scale score was 2.0, and the mean NTNH (Normalized Truncated Navicular Height) was 0.17.
Participant flow
3 of 22 participants were excluded from the analysis due to mechanical malfunctions or operator errors.
Adverse events
None
Outcome measures
knee valgus angles and moments at initial contact and at peak vertical ground reaction force during single-leg drop cutting
the maximum knee valgus angle during single-leg squat
Plan to share IPD
Individual participant data will not be shared to ensure the confidentiality of the participants.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 30 | Day |
Other
Other related information
This study is being registered retrospectively due to administrative delays. The study protocol was finalized and approved by the IRB prior to the start of data collection, and the study was conducted in strict accordance with the original plan.
Management information
Registered date
| 2026 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070216
