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临床试验/NCT03373890
NCT03373890已完成不适用

Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups

研究概览

简要总结

This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.

详细描述

Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.

This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.

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)

盲法说明

Muscle function assessor masked to frequency group, Muscle architecture captured via ultrasound Community walking activity collected by accelerometry, thus non-human data collection

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III

排除标准

  • undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior

研究组 & 干预措施

Short burst Interval Treadmill Training High Frequency

Experimental

Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks

干预措施: Short Burst Interval Locomotor Treadmill Training (SBLTT) (Behavioral)

Short Burst Interval Treadmill Training Low Frequency

Active Comparator

Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks

干预措施: Short Burst Interval Locomotor Treadmill Training (SBLTT) (Behavioral)

结局指标

主要结局

Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups

时间窗: Change from baseline to immediately post SBLTT

Average Strides/day \> 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups

Change in Walking Performance High Versus Low Frequency SBLTT Groups

时间窗: Change from baseline to immediately post SBLTT

Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable

Change in Walking Capacity High Versus Low Frequency SBLTT Groups

时间窗: Change from baseline to immediately post SBLT.

Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups

Change in Walking Endurance- High Versus Low Frequency SBLTT Groups

时间窗: Change from baseline to immediately post SBLTT

Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups

次要结局

  • Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups(Change from baseline to 6 weeks post SBLTT)
  • Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups(Change from baseline to immediately post SBLTT)
  • Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups(Change from baseline to immediately post SBLTT)
  • Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups(Change from baseline to immediately post SBLTT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristie Bjornson

Associate Professor, Pediatrics

Seattle Children's Hospital

研究点 (2)

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