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临床试验/NCT05233748
NCT05233748已完成不适用

Neuromotor Control During Walking in Children With Cerebral Palsy

University of Delaware2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年10月30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
34
试验地点
2
主要终点
Change in Margin of Stability(MOS)

研究概览

简要总结

One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. In this project, we will use small electrical stimulation of muscles and tendons that enhances the sense of body positioning, to allow children with CP to generate more accurate balance corrections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

The SRopt and noSR conditions will be presented in random order generated by a computer program and the subjects will be blinded to either condition, due to SR stimulation being below the sensory threshold i.e subjects do not perceive the stimulation at all.

入排标准

年龄范围
8 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 8 - 24 years
  • Diagnosis of spastic diplegic or hemiplegic CP (for participants with CP group only)
  • GMFCS classification level I or II (ability to walk independently with using any assistive device)
  • Visual, perceptual, and cognitive/ communication skills to follow multiple step commands
  • Seizure-free or well controlled seizures
  • Ability to communicate pain or discomfort during testing procedures
  • Parental/guardian consent and child assent/consent

排除标准

  • Diagnosis of athetoid, ataxic or quadriplegic CP
  • Significant scoliosis (scoliometer angle > 9°)
  • History of selective dorsal root rhizotomy
  • Botox injections in the lower limb within the past 6 months
  • Severe spasticity of the lower extremity muscles (e.g. a score of 4 on the Modified Ashworth Scale)
  • Severely limited range of motion/ irreversible muscle contractures
  • Lower extremity surgery or fractures in the year prior testing
  • Joint instability or dislocation in the lower extremities
  • Marked visual or hearing deficits

结局指标

主要结局

Change in Margin of Stability(MOS)

时间窗: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.

MOS refers to the distance between extrapolated center of mass (which includes center of mass position and velocity) and the base of support. It has been previously used to measure balance in children with cerebral palsy, patients with stroke, Parkinson Disease, and Multiple Sclerosis. We will measure center of mass using kinetics and kinematic computed through a motion capture system(Qualysis). For the visual perturbation conditions, we will use center of mass excursion as the primary outcome measure (since it has been used in prior studies in children and adults using visual perturbation protocols).

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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