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

NCT05306886 | Completed

• 1 other identifier: AIBU-FTR-BENLI-003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Standing Long Jump Test

  Eight weeks

• 10 Meter Walk Test

  Eight weeks

• Shuttle Running Test

  Eight weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

ICB Special Insoles

Other: ICB Medical Insoles

Control group

ACTIVE COMPARATOR

ICB Insoles

Other: ICM Insoles

Interventions

ICB Medical Insoles OTHER

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.

Intervention group

ICM Insoles OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Having a minimum 5 degree subtalar pronation angle while standing,
• \. A minimum score of +6 from the Foot Posture Index (API) scale
• \. Being between the ages of 18-45
• \. Not having received any treatment from the foot area in the last 6 months
• \. To have cognitive competence

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University Faculty of Health Science

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

Study Officials

• Ramazan Kurul

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 16, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

TU (1)