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

A

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,
    1. A minimum score of +6 from the Foot Posture Index (API) scale
    1. Being between the ages of 18-45
    1. Not having received any treatment from the foot area in the last 6 months
    1. To have cognitive competence

Exclusion criteria

    1. End of volunteering
    1. Having a history of surgery of the lower extremity
    1. Being an active athlete
    1. Being pregnant or diagnosed with malignancy
    1. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
    1. Lower extremity inequality greater than 1 centimeter (cm)
    1. Having a different orthopedic disease that may affect lower extremity biomechanics
    1. Receiving a different treatment for pes planus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

1

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Central trial contact

Ramazan Kurul, Ph.D; Muhammed Ögün, M.D

Data sourced from clinicaltrials.gov

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