Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Walking Capacity-Fast walking speed
研究概览
简要总结
Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting their walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. In order to optimize motor learning, active participation, task-specific training and multiple repetitions or massed practice is required to learn new motor skills. Short bursts of vigorous intensity locomotor treadmill training (SBLTT) alternating with low/moderate intensity was specifically designed to mimic activity patterns of TD children in a massed practice format. Pilot data suggests that SBLTT is feasible and enhances walking capacity and performance in daily life for children with CP. This project will examine the effect of SBLTT versus an equivalent dosage of traditional locomotor treadmill training (TLTT) on the primary outcomes of walking capacity and performance in children with CP and whether the effects of SBLTT on walking capacity and performance are mediated by improvements in in muscle power generation. The scientific premise is that SBLTT, that approximates the walking intensity patterns of typically developing (TD) children through a home-based massed practice protocol, will be more effective than TLTT in improving walking capacity and performance. We hypothesize that SBLTT strategies for children with CP modeled on walking patterns of TD children, will be positively mediated by muscle power generation and subsequently improve walking capacity and community walking performance and mobility. Specific aims. Aim #1. Determine the immediate and retention effects of short-burst interval LTT (SBLTT) on walking capacity in ambulatory children with CP. Aim #2. Examine the effects of treatment on community-based walking activity performance and mobility. Aim #3. Explore whether the effects of SBLTT on walking capacity and performance are mediated by muscle power generation. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively effecting the community walking performance and mobility for children with CP.
详细描述
In a randomized clinical trial, 72 ambulatory children with spastic CP (6-10 yrs.) will receive either SBLTT or an equivalent dosage of TLTT for 40 sessions, 5x/week for 8 weeks in a massed practice format. The only difference between training protocols will be the variable training (interval fast versus steady state walking speeds). Thus, the key ingredient will be the intensity of the interval training delivered in a serial blocked practice schedule. Outcomes will be collected at baseline, 4 and 8 weeks to assess dosage, and 24 weeks post training for long term retention with the primary endpoint at 8 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral and unilateral spastic cerebral palsy
- •Gross Motor Function Classification Levels II & III
- •Ages 6 years to < 11 years
排除标准
- •Orthopedic or neurosurgery < 9 months prior
- •Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
结局指标
主要结局
Walking Capacity-Fast walking speed
时间窗: Baseline to 8 weeks
10 Meter Walk Test- fast speed
Walking Capacity-Endurance
时间窗: Baseline to 8 weeks
One Minute Walk Test
Knee extensor muscle power
时间窗: Baseline to 8 weeks.
Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.
Walking Performance-level
时间窗: Baseline to 8 weeks
StepWatch (SW) accelerometry - average total steps per day
Walking Capacity-Self-selected walking speed
时间窗: Baseline to 8 weeks
10 Meter Walk Test
Walking Capacity-Fast walking speed
时间窗: Baseline to 8 weeks
10 Meter Walk Test- fast speed
Walking Capacity-Endurance
时间窗: Baseline to 8 weeks
One Minute Walk Test
Walking Performance-level
时间窗: Baseline to 8 weeks
StepWatch (SW) accelerometry - average total steps per day
Walking Performance-Intensity
时间窗: Baseline to 8 weeks
StepWatch (SW) accelerometry - percent of strides/day in medium/high stride rates.
Knee extensor muscle power
时间窗: Baseline to 8 weeks.
Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.
次要结局
- Family Gait Priorities and Quality of gait(Baseline to 8 weeks)
- Knee extensor muscle torque(Baseline to 8 weeks.)
- Family Gait Priorities and Quality of gait(Baseline to 8 weeks)
- Walking Mobility-intensity community(Baseline to 8 weeks)
- Knee extensor muscle torque(Baseline to 8 weeks.)
- Walking Mobility -level home(Baseline to 8 weeks)
- Walking Mobility-intensity home(Baseline to 8 weeks)
- Walking Mobility -level community(Baseline to 8 weeks)
- Mobility-Patient Reported Outcome(Baseline to 8 weeks)
研究者
Kristie Bjornson
Professor, Pediatrics
Seattle Children's Hospital