Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
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: In-home standing and walking intervention.
- Кому может быть актуально
- Состояния в реестре: Cerebral Palsy. Базовые параметры: 5 мес. — 2 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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Обзор
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of cerebral palsy.
Подробное описание
Seventy percent of children with cerebral palsy (CP) will walk, yet walking occurs much later than typically-developing children and may require use of a walker or crutches. The walking impairment is caused by an early lesion to the motor areas of the brain which disrupts the formation of appropriate neural connections, specifically projections of the corticospinal tract from the motor cortex to spinal cord motor circuits. The critical period of lower extremity neuromotor development, when intervention is expected to be most effective, begins before 12 months of age with the establishment of appropriate spinal connections and extends to 2 years of age with the presence of mature myelin in the corticospinal tract at the lumbar level. Based on this research, we propose that to optimize future walking outcomes of individuals with CP, it is critical to promote standing and walking practice during infancy before the age of 12 months.
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of CP. Eight infants with or at high risk of CP will enter the study at 5 to 12-months of age. All infants will participate in 3 conditions: 8-weeks no intervention baseline, 16-weeks intervention, and 8-weeks no intervention follow-up. During the intervention weeks, parents will implement the in-home intensive standing and walking intervention with body-weight support 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to progress the program. The body-weight support system allows infants to independently explore a 9 by 9-foot space in standing without physical assist from their parents or other adults.
Outcomes will be measured at baseline, monthly throughout the 8 month study, and at 2 years of age. Feasibility of implementing the interventions will be assessed. Secondary outcomes will include standardized assessments of motor, cognitive, and language development of the infants.
Вмешательства
- Поведенческое In-home standing and walking intervention
Parents/legal guardians will be educated on and provided an activity booklet on intensive standing and walking play activities for their infant in a 9 by 9 foot body-weight support system (BWS). Activities include: squatting play at a couch or table, cruising along and between furniture, walking with a push toy or with one or two hands held, walking without support, and kicking and throwing a soft ball. For 16 weeks, parents/legal guardians will be encouraged to implement the parent-led, intens
Первичные конечные точки
- Feasibility of the in-home standing and walking intervention [Срок оценки: 4 months]
Вторичные конечные точки (2)
- Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4) [Срок оценки: 2 years]
- Gross Motor Function Measure (GMFM-88) [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Infants with or at high risk of cerebral palsy (CP) who either:
- have been diagnosed with CP by a medical professional, or
- are at high risk of CP defined as having both:
- clinical brain imaging indicating CP, such as (i) white matter injury (cystic periventricular leukomalacia or periventricular hemorrhagic infarctions), (ii) hypoxic-ischemic encephalopathy, or (iii) neonatal stroke, and
- a score less than 63 or more than 5 asymmetries on the Hammersmith Infant Neurological Examination (HINE).
Критерии исключения
- prenatal substance abuse,
- congenital malformations,
- drug-resistant epilepsy,
- visual impairment that hinders the infant from seeing toys,
- hearing impairment that hinders the infant from responding to sound,
- living in a location inaccessible by study personnel for in-home data collections,
- participant over 50 lbs in weight.
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
- Другое
Центры проведения
США · 1 центр
- University of Southern California — Los Angeles
Идентификаторы
NCT: NCT05781438 · UP-22-00866