Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Seated Postural and Reaching Control (SP&R-co)
研究概览
简要总结
The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children.
Aim 1 is a cross-sectional study. In this single-session, kinematic and muscle activity data will be collected during the postural static, active-proactive, and reactive postural head tasks. Gross Motor Functional Classification System (GMFCS) levels will also be collected to categorize the sample into subgroups.
Aim 2 is a prospective cohort quasi-experimental study. The data will be collected at baseline, across 12 intervention sessions, 1 week post-intervention, and 3 months follow-up.
Functional assessments will be used to compare across the pre, mid, and post training. Participants will be assessed in Gross Motor Functional Measures (GMFM), Seated Posture and Reaching Control (SP&R-co), and Canadian Occupational and Performance Measure (COPM). The primary outcomes will be SP&R-co test and COPM pre- and post-intervention.
详细描述
The study investigators plan to recruit a sample of 30 children and adults (10 able-bodied children/young adults for the characterization phase and 20 children/young adults with bilateral cerebral palsy: 10 classified as GMFCS IV and 10 classified as GMFCS V). These participants will be aged 11-21 years.
A motion capture/body mounted sensors and Electromyography (EMG) system will be used for measurement. This study will utilize specialized robotics that can apply gentle forces on the head-neck during movement training using the principles of motor learning.
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
盲法说明
This is an exploratory study.
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
- 是
入选标准
- •CP, as medical diagnosis
- •GMFCS IV-V classification
排除标准
- •severe cognitive deficits
- •uncontrolled epilepsy
- •severe dyskinesia
- •spinal cord malformations
- •severe vertebral column deformities (scoliosis >40° and/or kyphosis >45º)
- •blindness
- •chemo-denervation 3 months before study
研究组 & 干预措施
Device
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
干预措施: Neck Brace Device (Device)
结局指标
主要结局
Seated Postural and Reaching Control (SP&R-co)
时间窗: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
Measurement of head-trunk and reaching control of children and young adults with CP while sitting static, active, proactive, and reactive postural dimensions while providing support at different regions of the torso.
次要结局
- Gross Motor Functional Measure-items set (GMFM-IS)(Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.)
- Canadian Occupational Performance Outcome (COPM)(Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.)
研究者
Sunil Agrawal
Professor
Columbia University