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临床试验/NCT05306886
NCT05306886已完成不适用

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

Abant Izzet Baysal University2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
The Physical Activity Assessment Questionnaire (IPAQ) Short Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The Physical Activity Assessment Questionnaire (IPAQ) Short Form

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ramazan KURUL

Assistant Professor

Abant Izzet Baysal University

研究点 (2)

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