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临床试验/NCT04884386
NCT04884386已完成不适用

Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial

Sahmyook University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年6月12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
22
试验地点
2
主要终点
muscle activation

研究概览

简要总结

In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
  • Patients diagnosed with Bilateral Spastic Cerebral Palsy
  • Patients diagnosed with Spastic Hemiplegic Cerebral Palsy

排除标准

  • Children who cannot understand and follow orders
  • Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
  • Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
  • Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more

结局指标

主要结局

muscle activation

时间窗: Change from baseline muscle activation at 4 weeks

Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do

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

collaborator

Sahmyook University

研究点 (2)

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