跳至主要内容
临床试验/NCT06320288
NCT06320288招募中不适用

Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
270
试验地点
1
主要终点
Trunk and center-of-mass accelerations and acceleration variability

研究概览

简要总结

During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Children (< 18 years) with cerebral palsy
  • GMFCS I to III
  • Independent walking with or without technical walking aids (walker, crutches, etc.)
  • Able to understand the instructions of various clinical assessments and functional explorations
  • Affiliated with a social security scheme

排除标准

  • Children with cerebral palsy
  • Neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months
  • Botulinum toxin A injections within the last 6 months
  • Therapeutic intervention targeting trunk control last 6 months
  • Typically developing children
  • Surgery on lower limbs or trunk last 12 months
  • Neurological and/or orthopedic pathology that may influence gait

研究组 & 干预措施

Children with cerebral palsy

All children will undergo :

  • A neuro-articular assessment
  • A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking.
  • Assessment of gross motor function
  • Static posturography
  • Functional assessment of the trunk
  • Functional assessment of balance

Children with typical development

All children will undergo :

  • A neuro-articular assessment
  • A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking.
  • Static posturography
  • Functional assessment of the trunk
  • Functional assessment of balance

结局指标

主要结局

Trunk and center-of-mass accelerations and acceleration variability

时间窗: At the end of the one-day experimental

In addition to the zeno walking track, inertial computers will be used to record accelerations of the patient's trunk and center of mass as they walk. One will be attached to the sternum, the other to the lumbosacral hinge, using hypoallergenic double-sided tape. A third will be attached to the patient's shoe to synchronize the data from the treadmill and the inertial units. Acceleration variability is calculated in post-processing.

次要结局

  • Gait Variability Index(At the beginning of the one-day experimental)
  • Early Clinical Assessment of Balance score(At the beginning of the one-day experimental)
  • Trunk Control Measurement Scale score (TCMS)(At the beginning of the one-day experimental)

研究者

发起方
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
申办方类型
Other
责任方
Sponsor

研究点 (1)

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