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Clinical Trials/NCT05306886
NCT05306886
Completed
Not Applicable

Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances

Abant Izzet Baysal University1 site in 1 country45 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Flat Foot [Pes Planus] (Acquired), Unspecified Foot
Sponsor
Abant Izzet Baysal University
Enrollment
45
Locations
1
Primary Endpoint
The Physical Activity Assessment Questionnaire (IPAQ) Short Form
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
June 16, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ramazan KURUL

Assistant Professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

The Physical Activity Assessment Questionnaire (IPAQ) Short Form

Time Frame: 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

Time Frame: 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 Outcomes

  • 10 Meter Walk Test(Eight weeks)
  • Standing Long Jump Test(Eight weeks)
  • Shuttle Running Test(Eight weeks)

Study Sites (1)

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