跳至主要内容
临床试验/NCT04630392
NCT04630392招募中不适用

Effects of the Addition of a Single Bout of Whole-Body Vibration to a Single Bout of Treadmill Training on Gait and Spasticity in Ambulatory Children With Cerebral Palsy

Georgia State University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Overground gait step length

研究概览

简要总结

Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.

详细描述

Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. The evidence supporting the use of TT in children with cerebral palsy (CP) remains inconclusive, but WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.

The investigators plan to recruit 20 children between the ages of 6 and 17 with spastic CP. Subjects will complete a 10-minute bout of TT at 110% of their preferred overground (OG) walking speed, rest for 15 minutes, and then complete a 12-minute bout of WBV at 20Hz and 2mm followed by a second 10-minute bout of TT at the same speed. OG gait characteristics, including spatiotemporal parameters, joint kinematics, and electromyographic (EMG) parameters, will be collected at 5 time points: before the first bout of TT, immediately following the first bout of TT, before WBV, immediately following WBV, and immediately following the second bout of TT. Lower extremity spasticity will be assessed using multiple methods at the same time points. Changes in gait parameters and spasticity will be assessed using a one-way repeated measures ANOVA and a series of dependent t-tests. Significant level will be set at α = 0.05.

The investigators anticipate that acute improvements in OG gait parameters will be greater following the combined bout of WBV and TT than the bout of TT alone. The investigators expect this to be due to the reduction of lower extremity spasticity following WBV, which should allow for more normalized gait patterns during TT and improve carryover to OG gait. Further, the investigators expect to gain insight into the mechanisms responsible for spasticity reduction following WBV which will allow for the making of informed decisions regarding clinical rehabilitative protocols involving WBV and TT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • a medical diagnosis of spastic CP
  • a GMFCS level of I, II, or III
  • age of 6-17 years at the time of data collection

排除标准

  • history of musculoskeletal injury within the past 3 months
  • history of Botox injections to the lower extremities within the past 3 months
  • history of significant cardiac abnormalities and/or uncontrolled seizures
  • any cognitive or behavioral issues that prevent the subject from safely following instructions while walking on the treadmill

研究组 & 干预措施

Intervention Group

Experimental

There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.

干预措施: Treadmill Training (Other)

Intervention Group

Experimental

There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.

干预措施: Whole Body Vibration & Treadmill Training (Other)

结局指标

主要结局

Overground gait step length

时间窗: immediately after intervention

Measured in cm from kinematic motion capture data

Overground gait muscle activity as measured by electromyographic sensors

时间窗: immediately after intervention

integrated area per gait cycle at the following muscles: biceps femoris, vastus lateralis, lateral gastrocnemius, tibialis anterior

Overground gait walking speed

时间窗: immediately after intervention

Measured in m/s from kinematic motion capture data

Overground gait dynamic knee range of motion

时间窗: immediately after intervention

Measured in degrees from kinematic motion capture data

Overground gait dynamic ankle range of motion

时间窗: immediately after intervention

Measured in degrees from kinematic motion capture data

Lower extremity spasticity as measured by the Modified Tardieu Test

时间窗: immediately after intervention

including R1 and R2 joint angles as well as qualitative score

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

Jianhua Wu

Professor

Georgia State University

研究点 (1)

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