Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Gross Motor Function Measure Dimension E
研究概览
简要总结
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.
详细描述
The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.
Hypotheses
- A more intensive protocol of treadmill training will increase walking onset in young children with CP.
- A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.
Specific Aims
- To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
- To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
- •Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
- •who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
- •who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
- •who have been identified as high-risk for a motor disability by a physician
排除标准
- •a history of uncontrolled seizures
- •a diagnosis of a genetic disorder
- •cardiac or orthopedic contraindications for standing and walking
- •orthopedic surgery in the past 6 months
- •use of spasticity-reducing medication or Botox injections in the past 6 months
结局指标
主要结局
Gross Motor Function Measure Dimension E
时间窗: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
Gross Motor Function Measure Dimension D
时间窗: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
Walking Activity Measured by StepWatch
时间窗: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
次要结局
- Pediatric Evaluation of Disability Index-Mobility Subscale(pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention)
- 1-minute Walk Test(assessed at 6 weeks, 1 month, 4 months)
- Peabody Developmental Motor Scales-2 -Locomotion Subscale(assessed at 6 weeks, at 1-month and at 4-months)
- Timed 10-meter Walk Test(assessed at 6 weeks, at 1-month and at 4-months following the intervention)
研究者
Katrin Mattern-Baxter
PT, DPT, PCS
California State University, Sacramento