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

Abant Izzet Baysal University

Status: Completed

Conditions: Flat Foot [Pes Planus] (Acquired), Unspecified Foot

Treatments: Other: ICM Insoles; Other: ICB Medical Insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT05306886

AIBU-FTR-BENLI-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Having a minimum 5 degree subtalar pronation angle while standing,
• 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

• 1. End of volunteering
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Intervention group

Experimental group

Description:

ICB Special Insoles

Treatment:

Other: ICB Medical Insoles

Control group

Active Comparator group

Description:

ICB Insoles

Treatment:

Other: ICM Insoles