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

Not Applicable

Completed

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

• Registration Number: NCT05306886
• Lead Sponsor: Abant Izzet Baysal University

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.

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 Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-01
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Physical Activity Assessment Questionnaire (IPAQ) Short Form	Eight weeks	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.
Flamingo Balance Test and Y Balance Test	Eight weeks	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.

Secondary Outcome Measures

Name	Time	Method
10 Meter Walk Test	Eight weeks	For functional performance10 Meter Walk test will be applied. Patient's will be asked to walk 10 meter. Time is measured while patients walk.
Standing Long Jump Test	Eight weeks	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.
Shuttle Running Test	Eight weeks	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.

Trial Locations

Locations (1)

Abant Izzet Baysal University Faculty of Health Science; 🇹🇷 Bolu, Merkez, Turkey