Understanding Perinatal Spinal Cord Injury
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Activity-Based Recovery Training, Transcutaneous Spinal Cord Stimulation.
- Кому может быть актуально
- Состояния в реестре: Perinatal Spinal Cord Injury. Базовые параметры: 3 лет — 8 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
Обзор
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.
Подробное описание
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.
Aim 3: In children with chronic, cervical, perinatal SCIs, investigate the effect of 40 sessions of scTS paired with ABRT on autonomic functions, i.e., respiratory, blood pressure regulation, bladder/bowel.
Вмешательства
- Другое Activity-Based Recovery Training
ABRT uses task-specific training to improve neuromuscular capacity. ABRT will be tailored to participant presentation. Activity-Based Locomotor Training consists of stepping, standing, and sitting activities on a body weight support (BWS) treadmill using a harness and while overground. Therapists and trainers provide hands-on assistance for safety and kinematics. BWS is varied during sessions with a goal of optimal kinematics at the lowest BWS. Activities performed standing will focus on alignme - Устройство Transcutaneous Spinal Cord Stimulation
Transcutaneous Spinal Cord Stimulation (scTs) is a non-invasive stimulation administered over the skin using a modulated biphasic or monophasic waveform at 15-90Hz and a carrier frequency of 5-10kHz. Bouts of scTs at the cervical, thoracic, lumbar, and/or coccygeal level will be administered midline or just lateral to the spinous processes during activity-based recovery training.
Первичные конечные точки
- Participant Specific Outcome Measures [Срок оценки: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
Вторичные конечные точки (12)
- Supine Functional Neurophysiological Assessment (FNPA) [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Acoustic Startle Response (ASR) [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Somatosensory Evoked Potentials (SSEP) [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Stand/Step Functional Neurophysiological Assessment (FNPA) [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Upper Extremity Motor Control Assessment [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Trunk Motor Control Assessment [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Segmental Assessment of Trunk Control [Срок оценки: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Pediatric Neuromuscular Recovery Scale (NRS) [Срок оценки: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Spasticity of upper extremity and lower extremity [Срок оценки: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Respiratory Motor Control Assessment (RMCA) [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Bowel Questionnaire [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
- Overground Walking Assessment of Gait [Срок оценки: At study enrollment and following 40 sessions (approximately 2 months)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Louisville — Louisville
Идентификаторы
NCT: NCT06808035 · 23.0722