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临床试验/NCT05763901
NCT05763901已完成不适用

Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2021年4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
151
试验地点
2
主要终点
Evaluation and measurement of balance

研究概览

简要总结

While various complex pathologies of the developmental age, such as Infantile Cerebral Palsy or Neuromuscular Diseases, are notoriously considered causes of alteration of locomotor development, it is scarcely known whether conditions much more frequent in the pediatric population, the so-called "Paramorphisms or Dysmorphisms", may be associated with more or less noticeable changes in locomotor development.

On a few studies, flat feet and hyperlaxity has been correlated with a motor control delay or poorer motor performance, based on complex clinical tests or on stereophotogrammetry movement analysis.

Although promising, these preliminary studies, in addition to not providing information on the possible influence of other paramorphisms, such as varus and valgus of the knees, do not provide conclusive indications.

The aim of this study is to investigate, through clinical tests and wearable inertial units, the motor control of a pediatric population affected by Paramorphisms or Dysmorphisms and to compare them with a population of healthy controls, matched by age, taken from the recently developed control data set from Bisi and Stagni.

研究设计

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

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Born at term
  • Without known delay in motor development
  • Finding of one or more paramorphisms or dysmorphisms of the developmental age (flat or cavus foot, valgus or varus talipes, valgus or varus knee, scoliotic attitude or scoliosis, hyperkyphosis or hyperlordosis, generalized or focused hyperlaxity, heterometry of the AAII, torsional defects AAII)

排除标准

  • Preterm birth
  • Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)

结局指标

主要结局

Evaluation and measurement of balance

时间窗: Baseline

Evaluation of balance using clinical tests ( Movement ABC2).

Evaluation and measurement motor competence

时间窗: Baseline

Evaluation of motor competence using clinical tests (Test of Motor Competence, ).

Measurement of balance

时间窗: Baseline

Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.

Measurement of motor competence

时间窗: Baseline

Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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