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临床试验/NCT06705673
NCT06705673尚未招募不适用

Investigation of Gait Profile and Variables of Children and Adolescents with Pediatric Rheumatic Disease Using a Smart Insole System

Istanbul University - Cerrahpasa0 个研究点目标入组 60 人开始时间: 2024年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Stance Duration

研究概览

简要总结

In pediatric rheumatic diseases, joint swelling, effusion, tenderness, and painful restriction of joint movement, particularly in weight-bearing joints, frequently alter walking function. These changes affect temporal and spatial parameters of gait, as well as kinematic and kinetic characteristics, leading to functional limitations. Comprehensive physical assessments in patients may not always predict changes in gait parameters. Therefore, incorporating objective methods related to gait and balance into physical evaluations is essential for functional insights and clinical decision-making, aiming to prevent adaptive mechanisms that could negatively affect gait function in the long term. In this context, smart insoles have emerged as a new tool for gait analysis, offering an alternative to high-cost, lab-based equipment. The Digitsole Pro® system can measure gait profile and variables in real-life conditions. A review of the literature reveals no studies utilizing smart insole-based gait assessments in pediatric rheumatic patients. The aim of our study is to investigate the gait profile and variables of children and adolescents with pediatric rheumatic disease using the next-generation Digitsole Pro® smart insole system, and to compare the results with those of healthy peers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children and adolescents with pediatric rheumatic disease:
  • Aged 6-18 years
  • Diagnosed with JIA or FMF at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic
  • Healthy children and adolescents:
  • Aged 6-18 years
  • Willing to participate in the study

排除标准

  • Exclusion criteria for children and adolescents with pediatric rheumatic disease:
  • History of trauma or surgery affecting the musculoskeletal system in the last 6 months
  • Presence of a chronic disease other than JIA or FMF
  • Acute pain for any reason
  • Visual or hearing problems
  • Cognitive impairment that prevents understanding of given instructions
  • Exclusion criteria for healthy children and adolescents:
  • History of trauma or surgery affecting the musculoskeletal system in the last 6 months
  • Hearing or visual problems
  • Acute pain for any reason

结局指标

主要结局

Stance Duration

时间窗: Baseline

Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.

Percentage of swing time

时间窗: Baseline

Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.

Walking speed

时间窗: Baseline

Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.

Double Support Time

时间窗: Baseline

Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.

Heel Strike Angle

时间窗: Baseline

Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.

Heel-Off Angle

时间窗: Baseline

Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.

Step Length

时间窗: Baseline

Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.

Cadance

时间窗: Baseline

Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.

Flat Foot

时间窗: Baseline

Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asya Albayrak

MSc

Istanbul Kent University

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