跳至主要内容
临床试验/NCT07000838
NCT07000838招募中不适用

Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation

University of Milan2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年5月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
2
主要终点
FHSQ

研究概览

简要总结

Foot hyperpronation is a common postural condition that can lead to pain, deformities (such as hallux valgus), and muscular issues. This problem is especially relevant among adults who spend long hours standing, such as healthcare workers. Custom-made foot orthoses with a medial wedge have proven effective in improving comfort and correcting certain biomechanical alterations, even in asymptomatic individuals.

The study described has two main objectives:

  • to validate the Italian version of the Foot Health Status Questionnaire (FHSQ), already validated in English and Spanish, by assessing its reliability and reproducibility as a tool to measure foot health.
  • through a pilot study, to analyze the effects of using specific professional footwear in healthcare workers with hyperpronation, evaluating perceived benefits in terms of pain reduction and postural improvement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthworker (attendings, residents, OR nurses, ER nurses, therapists...)
  • Maximum age inferior to 65 y.o. at recruitment time
  • Partecipants stands from 60% to 80% of their working time
  • Uses mostly healthcare shoes while working
  • Hyperpronation condition
  • No other pathologic condition of the feet
  • Partecipants accept to wear medially wedged orthesis for at least 3 months
  • Signatures of consensus to join the study
  • Partecipants must be aware of the implication of the study

排除标准

  • Other pathologic condition of the foot
  • Age superiore to 65 y.o. at the recruitment time

结局指标

主要结局

FHSQ

时间窗: 3 months

Assessment and description of the clinical conditions of the partecipants

次要结局

  • GAITLAB(Baseline)

研究者

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

Pietro Randelli, MD

Prof., MD

University of Milan

研究点 (2)

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