Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb
研究概览
简要总结
This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.
详细描述
Participants will be assessed 2 times - before and after training with the robot. All the testing and training sessions will be carried out at Spaulding Rehabilitation Hospital and will include:
Clinical tests:
- A test to evaluate gross motor function
- A test to assess walking speed
- A test to assess endurance
Muscle activity tests:
- A test to derive detailed measures of how well participant walk using a camera-based motion capture system.
- Special sensors (called electromyographic - EMG - sensors) will be used to determine when and how muscles are recruited to generate movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spastic cerebral palsy
- •6 to 18 years of age
- •Gross Motor Function (GMFCS) Level I, II, III or IV
- •Femoral length < size of robotic exoskeleton used for gait training (femur length between 210-350mm)
- •Ability to communicate pain or discomfort
排除标准
- •Recent use of Lokomat within the last 3 months
- •Contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis)
- •Skin ulcers in trunk or lower limbs
- •Hip, knee, ankle arthrodesis
结局指标
主要结局
Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb
时间窗: Data collected at baseline and at completion of the 7-week intervention
Surface electromyographic (EMG) data collected from 16 muscles of the lower limbs during overground gait will be analyzed using the non-negative matrix factorization technique to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated for the EMG recordings collected pre- and post-intervention. Cosine similarity values will range between 0 and 1, where 1 means that the patterns of co-activation are identical to normative whereas 0 means that they are completely different (as they do not overlap). The percentage of muscle synergies displaying an increase in cosine similarity will be reported.
次要结局
- Change in Gross Motor Function Measure (GMFM) Dimension D(Data collected at baseline and at completion of the 7-week intervention)
- Percent Change in 6-Minutes Walk Test(Data collected at baseline and at completion of the 7-week intervention)
- Percent Change in Edinburgh Visual Gait Scores (EVGS)(Data collected at baseline and at completion of the 7-week intervention)
- Change in Gross Motor Function Measure (GMFM) Dimension E(Data collected at baseline and at completion of the 7-week intervention)
- Percent Change in 10-Meter Walk Test(Data collected at baseline and at completion of the 7-week intervention)
研究者
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital