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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043731
Receipt No. 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 2021/03/25

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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
Email 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
Email sato-ken@hus.ac.jp

Sponsor
Institute Hokkaido University of Science
Institute
Department

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
Email 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
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
2021 Year 03 Month 25 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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