Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility of the in-home standing and walking intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
In-home standing and walking intervention
Infants will participate in the in-home standing and walking intervention for 16 weeks. In addition, infants will continue with any intervention in the community recommended by their health care team.
干预措施: In-home standing and walking intervention (Behavioral)
结局指标
主要结局
Feasibility of the in-home standing and walking intervention
时间窗: 4 months
Feasibility will be quantified by: parent survey of the: (a) infants' level of enjoyment during the intervention, (b) ease of use of the body-weight support system, (c) time participating in intervention, (d) time to put child in and take child out of the body-weight support, (e) perception of the effect of the intervention on the infant's motor skills, (f) perception of the effects of the intervention on the infant's non-motor skills (cognition, social, language), (g) overall perception of intervention as beneficial. The parent survey is on a likert scale from 1 to 5; a higher score denotes a better outcome.
次要结局
- Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)(2 years)
- Gross Motor Function Measure (GMFM-88)(2 years)
研究者
Barbara Sargent
Associate Professor of Clinical Physical Therapy
University of Southern California