UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043731 |
|---|---|
| Receipt number | R000049934 |
| Scientific Title | The Effect of the Use of a Foot Orthosis on the Shock Absorption Capacity of the Knee Joint in the Case of Excessive Rotation of the Subtalar Joint |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/05/16 10:50:31 |
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Basic information
Public title
Effect of using insoles to correct flat feet on knee joint shock absorption capacity
Acronym
Effect of Insole Use on Knee Joint Shock Absorption Capacity
Scientific Title
The Effect of the Use of a Foot Orthosis on the Shock Absorption Capacity of the Knee Joint in the Case of Excessive Rotation of the Subtalar Joint
Scientific Title:Acronym
The Effect of the Use of Foot Orthoses on the Shock Absorption Capacity of the Knee Joint
Region
| Japan |
Condition
Condition
Over Pronation of the subtalar joint
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the Q-angle, knee joint shock-absorbing ability, and quadriceps muscle activity during task activities (walking, single-leg drop-jump landing test) of a patient with a lower medial longitudinal arch due to over-rotation of the subtalar joint and whose alignment could be corrected to a neutral position by using a plantar orthosis made in the corrective position and a flat plate with the same thickness just below the calcaneus as the plantar orthosis. The purpose of this study was to investigate the immediate effects of using a plantar orthosis by comparing the Q-angle, knee joint shock absorption capacity, and quadriceps muscle activity during task movements (walking, one-legged drop-jump landing test) when a flat plate with the same thickness as the plantar orthosis was used.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Q-angle in standing position, CoA at knee joint, EMG potential of vastus lateralis
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The patient is asked to wear the Foot orthosis, which is made in a position with a neutral correction of the subtalar joint, during the measurement and finishes wearing it when the measurement is completed.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The arch efficiency of the medial longitudinal arch in the upright position is less than 16.4% in males and 14.6% in females due to over-rotation of the subtalar joint, and the patient should be able to correct the alignment with a Foot orthosis.
Key exclusion criteria
Subjects with a history of severe orthopedic and neurological conditions, such as marked deformity of the lower extremities or surgery other than hyperextension of the talonavicular joint, will be excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | kento |
| Middle name | |
| Last name | sato |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
15-4-1 Maeda 7-jo Teineku Sapporo-shi
TEL
011-688-2303
sato-ken@hus.ac.jp
Public contact
Name of contact person
| 1st name | kento |
| Middle name | |
| Last name | sato |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
15-4-1 Maeda 7-jo Teineku Sapporo-shi
TEL
011-688-2303
Homepage URL
sato-ken@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
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
15-4-1 Maeda 7-jo Teineku Sapporo-shi
Tel
011-688-2303
sato-ken@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
8
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Awaiting publication of the journal
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049934
