Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 10-Meter Walk Test
研究概览
简要总结
This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
详细描述
Objectives:
- To determine the use of the CPWalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population.
- To create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation.
Hypothesis:
- CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
- Performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels
- Following 16-24 CPWalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements
Procedures:
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
- 11 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Cerebral Palsy with spastic diplegia
- •Gross Motor Function Classification System score of 2-4
- •Age 11-21 at time of enrollment
- •Maximum weight of 75kg
- •Height range of approximately 110cm to 170cm
- •Ability to understand and follow verbal cues
- •Lower limb measurements meet specifications of CPWalker
- •Cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator
排除标准
- •Any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections
- •Severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. Patients may be able to wear their AFOs in the CPWalker if it allows for safe fit.
- •Unhealed wounds/lesions
- •Critical motor control alterations such as dystonia, choreoathetosis, or ataxia
- •Aggressive or self-harming behavior
- •Severe cognitive impairments that prevent a subject from being able to understand the exercises an/or interact with the study staff
研究组 & 干预措施
CPWalker Robotic-Assisted Gait Training
Each subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours
干预措施: CPWalker Robotic Exoskeleton (Device)
结局指标
主要结局
10-Meter Walk Test
时间窗: Change from baseline gait speed at 8 weeks
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10-meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second.
次要结局
- Gillette Functional Assessment Questionnaire (FAQ)(Change in baseline report of ambulatory function at 8 weeks)
- GAITRite Data Collection(Change from baseline gait quality at 8 weeks)
- Child and Adolescent Scale of Participation(Change in children's baseline participation in activities at 8 weeks)
- Selective Control Assessment of Lower Extremity (SCALE)(Change from baseline selective voluntary motor control at 8 weeks)
- Pediatric Balance Scale(Change from baseline balance score at 8 weeks)
- Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)(Change from baseline gross motor function at 8 weeks)
- 6-Minute Walk Test(Change from baseline distance ambulated at 8 weeks)
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab