Mobility Exercises for Gait (MEG Neuroplasticity Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Brain Activity in Sensory Cortices - MEG
研究概览
简要总结
This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment.
详细描述
This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment. The study consists of a cohort of children with CP that will undergo an action-perception training protocol, a cohort that will undergo a high velocity power training protocol and a cohort that will undergo body weight supported treadmill training. Participants will be between the ages of 9-18 years and have gross motor function classification score levels between I-III. All participants will complete final initial baseline measures of their brain activity, mobility, muscle performance, and participation activity outside of the laboratory. After completing these tests, the children will undergo the respective physical therapy protocols for 8-weeks (3 days a week). After the 8-weeks of therapy, both groups will repeat the same tests that were completed at baseline. Follow-up assessment will consist of a physical therapist scheduling a time to visit the family at their house and ask them questions about the child's participation in activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sustained a brain injury around the time of birth or a diagnosis of Cerebral Palsy
- •Must be able walk without a wheelchair (GMFCS I-III)
排除标准
- •Children dependent on a wheel chair for mobility
- •Braces, permanent retainers, or metal in the head (creates artifact in the MEG)
- •Orthopedic surgery within last 6 months
- •Botulinum injections within the last 6 months
结局指标
主要结局
Change in Brain Activity in Sensory Cortices - MEG
时间窗: Baseline and 8 weeks
To assess the activity of the somatosensory cortices, a tactile stimulation will be applied to the bottom of the foot at the first metatarsal using a small airbladder. For each child, 120 paired-pulse trials will be collected using an inter-stimulus interval of 500 ms, and an inter-pair interval that randomly varied between 4.5 and 4.8 s.
Change in Brain Activity in Motor Cortices - MEG
时间窗: Baseline and 8 weeks
To assess the activity of the motor cortices, the child will produce an isometric knee extension force to match a target that is between 5-30% of his/her maximum voluntary force. The children will be instructed to perform the target matching task as rapidly and as accurately as possible. The MEG experiment will involve the child performing \~120 isometric target matching trials.
Change in Mobility - 10-Meter Walk
时间窗: Baseline and 8 weeks
The childs 10-meter preferred and fast-as-possible walking speeds will be evaluated. The children will complete three trials at each speed, and the mean of the respective trials will be the key metric. During these tests, the child will walk across a GaitRITE digital mat (CIR Systems, Sparta, NJ) that will quantify the walking speed, step length, step width and cadence.
Change in Mobility - 1-Minute Walk
时间窗: Baseline and 8 weeks
The child's walking endurance will be assessed by asking them to walk as far as possible for a one-minute time period. Cones will be placed at the ends of a 40-m hallway and the child will be asked to walk back and forth during the time period. During the walk the child will wear a heart-rate monitor and wireless accelerometers that are positioned on the lower back and feet. The heart-rate monitor will be used as an indirect measure of the child's physical fitness, while the accelerometers will be used assess the child's dynamic balance.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline and 3 Months Post and 6 Months Post Treatment)
- Change in Hoffmann Reflex (H-reflex)(Baseline and 8 weeks)
- Change in Resting Cortical Activity - MEG(Baseline and 8 weeks)
- Change in Mobility - Dynamic Gait Index(Baseline and 8 weeks)
- Change in Participation in Environment Measure for Children and Youth (PEM-CY)(Baseline and 3 Months Post and 6 Months Post Treatment)
- Change in Activity - Actograph(Baseline 2 week days and two weekends, Post Treatment 2 week days and two weekends)
- Change in Muscle Performance - Biodex(Baseline and 8 weeks)