Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Participant Specific Outcome Measures
研究概览
简要总结
The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.
详细描述
Infants who suffer perinatal spinal cord injuries (SCI) are injured during a critical period of neurological development. Confounded further by on-going development, they are particularly vulnerable to the consequences of SCI (e.g., paralysis and paresis, hypertonia, bladder/bowel dysfunction, respiratory compromise) on lifelong health, function, and quality of life. There are only 4 published case reports of the presentation and rehabilitation of perinatally injured children. Clinically, children with high cervical SCI compared to those with low level SCI exhibit slow and limited active upper and lower extremity (UE, LE) movements, high tone, and poor trunk control. Children with low cervical lesions have a more typical pattern of loss below the injury level. We intend to expand our understanding of the scope of perinatal SCI and its impact in order to address integrated, whole-body system rehabilitation.
The overall objective of this study is to deepen our understanding of pediatric perinatal cervical SCIs and then formulate tailored treatment strategies that encourage neuroplasticity, enhance functional capacity, and improve the overall quality of life of children. The results from this study will provide pilot data and evidence that we can comprehensively assess and develop a therapeutic roadmap to improve whole-body function in children with perinatal SCI.
This is a pilot, within subjects, repeated measures, pre-post design.
Aim 1: Investigate the impact of perinatal, cervical SCI comparing high (C2-3) and low (C4-6) injuries on a whole-body profile of health: neurophysiological, sensorimotor, autonomic.
Aim 2: In children with perinatal SCIs, investigate the effect of 40 sessions of tailored transcutaneous spinal stimulation (scTS) paired with activity-based restorative therapies (ABRTs) on neurophysiological profile (spinal pathway functional integrity) and sensorimotor function.
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
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with a perinatal (injured in utero or at birth), upper motor neuron spinal cord injury involving cervical spinal levels
- •discharged from inpatient hospitalization/inpatient rehabilitation
排除标准
- •Botox use within the past 3 months
- •Current oral baclofen or baclofen pump use
- •Musculoskeletal impairment limiting range of motion (e.g. severe scoliosis), unhealed fracture, or other medical impairment limiting study participation
- •History of allodynia (heightened skin sensitivity typically at the level of the lesion site)
- •History of scoliosis surgery
- •Ventilator-dependence
- •Unwillingness to wean from daytime use of thoroco/lumbosacral orthosis and ankle/foot orthosis during the intervention period
研究组 & 干预措施
Cervical Perinatal SCI
Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.
干预措施: Activity-Based Recovery Training (Other)
Cervical Perinatal SCI
Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.
干预措施: Transcutaneous Spinal Cord Stimulation (Device)
结局指标
主要结局
Participant Specific Outcome Measures
时间窗: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Participant specific outcomes measures will be identified at study initiation via parent interview. Parents will identify daily, functional tasks that the participant has difficulty or challenges performing at a practical, successful level. Functional tasks performed by the participant will be video recorded at study initiation, post-20 sessions, and post-40 intervention sessions. Metrics of task performance include success or failure of the task.
次要结局
- Supine Functional Neurophysiological Assessment (FNPA)(At study enrollment and following 40 sessions (approximately 2 months))
- Acoustic Startle Response (ASR)(At study enrollment and following 40 sessions (approximately 2 months))
- Somatosensory Evoked Potentials (SSEP)(At study enrollment and following 40 sessions (approximately 2 months))
- Upper Extremity Motor Control Assessment(At study enrollment and following 40 sessions (approximately 2 months))
- Trunk Motor Control Assessment(At study enrollment and following 40 sessions (approximately 2 months))
- Segmental Assessment of Trunk Control(At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months))
- Pediatric Neuromuscular Recovery Scale (NRS)(At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months))
- Spasticity of upper extremity and lower extremity(At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months))
- Respiratory Motor Control Assessment (RMCA)(At study enrollment and following 40 sessions (approximately 2 months))
- Bowel Questionnaire(At study enrollment and following 40 sessions (approximately 2 months))
- Overground Walking Assessment of Gait(At study enrollment and following 40 sessions (approximately 2 months))
- Bladder Questionnaire(At study enrollment and following 40 sessions (approximately 2 months))
- Gross Motor Function Measure-88 (GMFM-88)(At study enrollment and following 40 sessions (approximately 2 months))
- Stand/Step Functional Neurophysiological Assessment (FNPA)(At study enrollment and following 40 sessions (approximately 2 months))
研究者
Andrea L. Behrman, PhD, PT
Professor
University of Louisville