Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
NCT ID: NCT05306886
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2022-03-01
2023-06-16
Brief Summary
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Detailed Description
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Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.
Patients will be randomized according to the order of their arrival at the clinic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
ICB Special Insoles
ICB Medical Insoles
After the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist.
Control group
ICB Insoles
ICM Insoles
As in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group.
Interventions
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ICB Medical Insoles
After the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist.
ICM Insoles
As in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group.
Eligibility Criteria
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Inclusion Criteria
* 2\. A minimum score of +6 from the Foot Posture Index (API) scale
* 3\. Being between the ages of 18-45
* 4\. Not having received any treatment from the foot area in the last 6 months
* 5\. To have cognitive competence
Exclusion Criteria
* 2\. Having a history of surgery of the lower extremity
* 3\. Being an active athlete
* 4\. Being pregnant or diagnosed with malignancy
* 5\. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
* 6\. Lower extremity inequality greater than 1 centimeter (cm)
* 7\. Having a different orthopedic disease that may affect lower extremity biomechanics
* 8\. Receiving a different treatment for pes planus
18 Years
45 Years
ALL
No
Sponsors
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Abant Izzet Baysal University
OTHER
Responsible Party
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Ramazan KURUL
Assistant Professor
Principal Investigators
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Ramazan Kurul
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University
Locations
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Abant Izzet Baysal University Faculty of Health Science
Bolu, Merkez, Turkey (Türkiye)
Countries
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Other Identifiers
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AIBU-FTR-BENLI-003
Identifier Type: -
Identifier Source: org_study_id
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