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临床试验/NCT04909151
NCT04909151Unknown不适用

The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy

Sahmyook University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年6月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
39
试验地点
2
主要终点
Gait ability

研究概览

简要总结

Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.

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 (Participant)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 4-12 years old diagnosed with cerebral palsy
  • Children who have not received botulinum toxin treatment or surgery within 3 months
  • Children in stage 2 of the gross motor function system
  • Children who can express pain, fear, or discomfort on their own

排除标准

  • Severe lower extremity contracture and fracture
  • Bone instability
  • Osteoporosis
  • Severe bones grow disproportionately
  • Unhealed skin lesions on the lower extremities (thromboembolic disease)
  • Thromboembolic disease
  • Cardiovascular instability
  • Mild scoliosis with a Cobb's angle of more than 20 degrees

结局指标

主要结局

Gait ability

时间窗: Change from baseline gait ability at 6 weeks

Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.

次要结局

未报告次要终点

研究者

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

Hyun-Joong Kim

Principal Investigator

Sahmyook University

研究点 (2)

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