NCT05306886

Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients

Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Abant Izzet Baysal University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.

Detailed description

Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics. 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

• Flat Foot [Pes Planus] (Acquired), Unspecified Foot

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-06-15
• Completion: 2023-06-16
• First posted: 2022-04-01
• Last updated: 2024-04-22

Locations

1 site across 1 country: Turkey (Türkiye)