The Effects of a Powered Knee Orthosis on Gait Kinematics of Children With Knee Extension Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Initial effect: Sagittal knee joint kinematics
研究概览
简要总结
Crouch gait/walking, characterized by an 'over-flexed' knee when the leg is supporting body weight, is common in children with diagnoses of cerebral palsy, spina bifida and other incomplete spinal cord injuries. The "Agilik" is a leg exoskeleton device that aims to improve how children with crouch gait walk. In this study the investigators will quantify the improvement that the Agilik facilitates in children with crouch gait in two ways: 1) the difference the Agilik makes when the participants start using it, and 2) any 'training effects' that can be seen in barefoot walking after six sessions of training with the Agilik.
详细描述
Specific Aims:
Improving knee kinematics during gait, in children exhibiting crouch gait due to weakness, would help to mitigate the ensuing deleterious effects - pain, joint deformity, radiological abnormalities and loss of independent gait.
The primary goal of this protocol is to assess the effectiveness of a powered knee orthosis (the "Agilik", developed by Bionic Power) for gait in patients exhibiting crouch gait. The investigators will specifically focus on improvement in knee extension during stance in patients with crouch gait.
The primary goal is characterized by two hypotheses, and two respective objectives:
Hypothesis 1: Use of the Agilik in children with crouch gait will result in an immediate improvement in sagittal plane knee kinematics during gait, with particular focus on knee extension during stance phase.
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
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-19 years of age
- •Male or female
- •Able to understand and follow simple directions based on parent report and physician observation during history and physical examination
- •Able to provide verbal/written assent.
- •Less than 20 degrees of knee flexion contracture with hip extended in supine position.
- •Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
- •A measured foot-thigh angle of -10 to 25 degrees in prone position.
- •Based on clinical observation of gait pattern, the patient walks with crouch gait. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
- •Able to walk at least 10 feet without stopping with or without a walking aid.
排除标准
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time.
- •A history of a seizure in the past year.
结局指标
主要结局
Initial effect: Sagittal knee joint kinematics
时间窗: day 1
Maximum knee extension (measured in degrees) during the stance phase of gait will be compared between barefoot gait and gait while wearing the Agilik.
Training effect: Sagittal knee joint kinematics
时间窗: 6 weeks
Maximum knee extension (measured in degrees) during the stance phase of gait will be compared between barefoot gait at the start of the trial and barefoot gait after 6 weeks of weekly training sessions with the Agilik.
次要结局
- Initial effect: Sagittal knee kinetics(day 1)
- Initial effect: Velocity of gait(day 1)
- Training effect: Velocity of gait(6 weeks)
- Training effect: Sagittal knee kinetics(6 weeks)
- Initial effect: Step-length of gait(day 1)
- Training effect: Step-length of gait(6 weeks)
研究者
Timothy Bhatnagar
Principle Investigator
University of British Columbia