Sampling Therapeutic Effects and Progress in Cerebral Palsy (STEP-CP)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Timed up and go
研究概览
简要总结
Cerebral palsy (CP) results from an early brain injury that can have cascading effects on the neuromuscular system and often results in life-long mobility impairments. An extensive amount of research funding has been dedicated towards identifying physical therapy treatment strategies that will overcome the spectrum of mobility impairments seen in person with CP. Surveillance of the clinical trials conducted to date reveals that there are a limited number of gait training treatment strategies with sufficient evidence that they should be implemented into clinical practice. Rather the outcomes from the clinical trials have been mixed with some individuals responding very well to physical therapy, while others appear to have barriers that limit their breakthroughs. Unfortunately, we have a substantial knowledge gap in our ability to identify the neurophysiological fingerprint for those that will respond well to the latest physical therapy trends and those that will not respond as well. The investigators recent neuroimaging outcomes are the first to reveal that persons classified as non-responders based on the walking speed clinical outcomes tend to display alterations in the activity of the prefrontal and premotor cortical areas. Remarkably, these same cortical areas have also been identified as potential biomarkers for the recovery of adults that have incurred a stroke. Although these insights are groundbreaking, they are based on pre- and post-physical therapy assessments. This limits the investigators understanding of where in the course of the treatment that an individual may have diverged from optimizing their mobility. Identifying the neurophysiological basis for these divergent time points has the potential for revealing more refined biomarkers for identifying why an individual with CP doesn't respond to a specific treatment and treatment strategies for intervening on the treatment direction. For example, if the investigator's data shows that an individual that doesn't respond as well lacks neuroplastic changes in the cortical areas that process sensory information, then augmenting the therapy with tasks that heighten the attention and recognition of sensory information might promote new breakthroughs for the individual patient. The overall purpose of the STEP-CP investigation is to employ dense sampling methods to evaluate the week-by-week neuroplastic changes seen across the therapeutic intervention and evaluate how they are connected with the extent of the weekly clinical gains or lack thereof.
详细描述
The overall landscape of this investigation involves you undergoing an 8-week gait training intervention that will be led by a licensed physical therapist. You will initially complete a battery of baseline MEG neuroimaging and clinical mobility assessments. Each week of the physical therapy you will repeat the MEG neuroimaging and clinical mobility assessments to quantify the extent of the weekly neuroplastic and mobility gains. You will repeat the same baseline assessments upon completion of the 8-weeks of physical therapy.
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
- 16 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with a diagnosis of cerebral palsy.
排除标准
- •Participants not able to stand or initiate gait movement without assistance.
- •Unable to walk for 1-minute with or without a mobility aide (i.e., forearm crutches, wheeled walker)
- •Have had orthopedic surgery within the last 6 months.
- •Metal in their body that would preclude neuroimaging.
- •Current pregnancy or suspected pregnancy.
- •Currently on steroid medication (i.e., birth control).
研究组 & 干预措施
Gait Training Group
Participants receive a goal-directed gait training intervention
干预措施: Physical Therapy Gait Training (Behavioral)
结局指标
主要结局
Timed up and go
时间窗: Weekly until 8 weeks
This is a standard clinical test that is used to assess mobility and dynamic balance. The participant will start the test by sitting on a bench. The time it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return back to sitting on the bench will be the outcome measure.
1-minute Walk
时间窗: Weekly until 8 weeks
Cones that are separated by 12.8 meters will be placed on opposite ends of the clinic and the participant is asked to complete laps around the cones as fast-as-possible.
MEG Neuroimaging
时间窗: Weekly until 8 weeks
Participants will complete 3 tasks that will be used to quantify the neuroplastic changes in the brain areas that are involved in the control of a leg motor action, processing of somatosensory information and processing of basic visual information. The activity of the brain areas that are involved in the planning and generation of a leg motor action will be assessed with a visually cued task where the participant extends their right knee every time the cue is seen. The activity of the brain areas that process sensory information will be assessed with a paired-pulse, unilateral electrical stimulation that will be applied using electrodes that will be affixed to the skin overlying the right tibial nerve (DS7R; Digitimer, UK). The intensity of stimulation will be set to level that generates a subtle twitch in the toes. The activity of the brain areas that process basic visual information will be assessed by having the participant view a flickering dot on a screen.
10-meter walk
时间窗: Weekly until 8 weeks
Each participant's 10-meter preferred, and fast-as-possible walking speeds will be evaluated. Three trials will be completed at each speed, and the fastest of the respective trials will be the key metric. The respective assessments will occur on a digital mat (ProtoKinetics, Havertown PA) that will quantify the spatiotemporal gait kinematics.
次要结局
- Sleep/Activity Monitoring(Daily until 8 weeks)
- Pittsburg Sleep Quality Index (PSQI)(Weekly until 8 weeks)
- Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) Survey(Weekly until 8 weeks)
- Secondary Hormone measure(Daily until 8 weeks)
- Daily Menstrual Distress Questionnaire(Daily until 8 weeks)
研究者
Max Kurz
Principal Investigator, Director of PoWER Lab
Father Flanagan's Boys' Home
