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临床试验/NCT04303078
NCT04303078已完成不适用

Quantifying Energetic Demands of Walking for People With Cerebral Palsy

University of Washington1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Net Nondimensional Oxygen Cost

研究概览

简要总结

The purpose of this study is to examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk.

The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with walking and common sub-tasks of walking, such as supporting and stabilizing the body.

详细描述

Children with CP use large amounts of energy to walk and move, leading to fatigue and limiting participation. For people with CP the energetic cost of walking is on average over two times higher than typically-developing (TD) peers. This means that for people with CP, walking is as tiring as jogging or climbing stairs. An energetic cost of this magnitude restricts activities of daily living (ADL) and causes exhaustion.

While the investigators and many others have sought to reduce these energetic costs through surgical interventions, rehabilitation, orthotics, or other assistive devices, these strategies have failed to result in meaningful reductions in energy. To design strategies that successfully reduce walking costs, the investigators must first understand the underlying mechanisms contributing to elevated cost in people with CP. This basic-science research will provide the foundation to create evidence-based strategies to decrease energy costs, minimize fatigue, and increase quality of life for people with CP and other neurologic injuries.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8-17 years old
  • Diagnosed with bilateral cerebral palsy
  • Gross Motor Function Classification System II
  • No surgery within the last 9 months
  • No current baclofen pump or explantation in the last 2 months
  • No botulinum toxin or phenol injections in the last 2 months
  • Had a prior gait and motion analysis at Gillette Children's Specialty Healthcare
  • Participant and caregiver able to speak and read English
  • Ability to follow instructions
  • Inclusion Criteria for Controls:
  • 8-17 years old
  • Participant and caregiver able to speak and read English
  • Ability to follow instructions

排除标准

  • 未提供

研究组 & 干预措施

Typically Developing Children (Controls)

Other

Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.

干预措施: Varying levels of harness support during walking (Other)

Children with Cerebral Palsy (Cases)

Experimental

Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.

干预措施: Varying levels of harness support during walking (Other)

结局指标

主要结局

Net Nondimensional Oxygen Cost

时间窗: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)

Steady-state net nondimensional oxygen consumption while walking on a treadmill. Percent change in oxygen consumption was evaluated between baseline without support and with vertical and lateral support.

次要结局

  • Three-dimensional Gait Kinematics (Baseline)(Initial trial without support (5-minutes))
  • Three-dimensional Gait Kinematics (Support)(Trial with maximum support (5-minutes))
  • Three-dimensional Gait Kinetics (Baseline)(Initial trial without support (5-minutes))
  • Three-dimensional Gait Kinetics (Support)(Trial with maximum support (5-minutes))
  • Passive Joint Range of Motion(One-time research visit (15 minutes))
  • Selective Motor Control(One-time research visit (15 minutes))
  • Lower Extremity Strength(One-time research visit (15 minutes))

研究者

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

Katherine Steele

Associate Professor, Engineering

University of Washington

研究点 (1)

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