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临床试验/NCT06350240
NCT06350240招募中不适用

Investigation of the Effects of Textured Insoles and Exercise on Tactile Sense, Balance, Foot Load Distribution and Quality of Life in Children With Joint Hypermobility

Gazi University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Tactile sense

研究概览

简要总结

Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.

详细描述

It was planned to include 40 children with joint hypermobility in the project. Children's joint hypermobility will be determined by the Beighton Score. Children will be divided into two groups. Children in both groups will be offered an exercise program consisting of home and park activities that will improve their motor and sensory aspects. Children in the intervention group will be asked to additionally use textured insoles. Before and after the study, children's plantar foot tactile sense, balance, foot load distribution and quality of life will be evaluated. Pre- and post-treatment values and change values in both groups will be compared with each other.

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
Single (Investigator)

入排标准

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

入选标准

  • Children with a Beighton score of 6 and above
  • Being between the ages of 5-18
  • Being cooperative in the assessments and treatment
  • Having a body mass index between 18.5-24.9

排除标准

  • Having had any surgery or trauma in the last 6 months
  • Having any neurological, metabolic, rheumatological or chronic disease.
  • Having a vestibular system problem
  • Being diagnosed with Ehlers-Danlos Syndrome
  • Having foot wounds and anomalies that may affect sole sensation
  • Having chronic pain.

结局指标

主要结局

Tactile sense

时间窗: Through study completion, an average of 1 year

Tactile sensory evaluation was performed with Semmes-Weinstein Monofilaments.

Foot load distribution

时间窗: Through study completion, an average of 1 year

Diagnostic Support Baropodometer Footscan® 3D system will be used for static and dynamic pedobarographic analysis.

Balance

时间窗: Through study completion, an average of 1 year

Biodex Balance System will be used for static balance assessment. Functional reach test will be used for dynamic balance assessment. The child will be asked to stand sideways against the wall. Marking will be made from the tip of the third finger, with the child's arm flexed at 90 degrees. The child will be asked to reach forward as far as he can without taking a step, lifting his heels off the ground, and without changing his arm position. The third fingertip will be marked again and the distance between the two marks will be measured in centimeters

次要结局

  • Quality of life assessment(Through study completion, an average of 1 year)
  • Foot posture(Through study completion, an average of 1 year)

研究者

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

Kamile Uzun Akkaya

PhD

Gazi University

研究点 (2)

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