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

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.

Study Overview

• Status: Completed
• Conditions: Flat Foot [Pes Planus] (Acquired), Unspecified Foot
• Intervention / Treatment: Other: ICB Medical Insoles; Other: ICM Insoles

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Bolu, Merkez, Turkey, 14100
      • Abant Izzet Baysal University Faculty of Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; ICB Special Insoles	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.
Active Comparator: Control group; ICB Insoles	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Physical Activity Assessment Questionnaire (IPAQ) Short Form	This form will be used to measure physical activity levels. comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. Higher scores indicates better physical activity level.	Eight weeks
Flamingo Balance Test and Y Balance Test	This will be applied for balance evaluation.To assess the ability to balance successfully on a single leg. A stopwatch, metal beam 50cm long, 5cm high and 3cm wide needed for test procedure. The total number of falls or loss of balance in 60 seconds is recorded. Scoring tables are available in the Eurofit Manual.	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standing Long Jump Test	For functional performance Standing Long Jump test will be applied.The athlete stands behind a line marked on the ground with feet slightly apart. A two foot take¬off and landing is used, with swinging of the arms and bending of the knees to provide forward drive. The subject attempts to jump as far as possible, landing on both feet without falling backwards. Three attempts are allowed. The measurement is taken from take¬off line to the nearest point of contact on the landing (back of the heels). Record the longest distance jumped, the best of three attempts. The table below gives a rating scale for the standing long jump test for adults, based on personal experiences.	Eight weeks
10 Meter Walk Test	For functional performance10 Meter Walk test will be applied. Patient's will be asked to walk 10 meter. Time is measured while patients walk.	Eight weeks
Shuttle Running Test	For functional performance Shuttle Running Test will be applied. his test requires the person to run back and forth between two parallel lines as fast as possible. Set up two lines of cones 30 feet apart or use line markings, and place two blocks of wood or a similar object behind one of the lines.Two or more trails may be performed, and the quickest time is recorded. Results are recorded to the nearest tenth of a second.	Eight weeks

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Principal Investigator: Ramazan Kurul, Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: AIBU-FTR-BENLI-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No