Effect of Single Event Multi Level Chemoneurolysis With Dysport on Energy Expenditure and Walking Efficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Oxygen Consumption (ml/kg/Min)
研究概览
简要总结
This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.
详细描述
Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread type of CP being spastic CP which negatively affects physical function. Specifically it is reported that there is an increase in energy expenditure and oxygen consumption in children with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to be an effective treatment for patients with spasticity to reduce energy expenditure by increasing walking efficiency; however many of these studies have conflicting methodological approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis with Dysport® on energy expenditure and gait in children with spastic diplegia CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 5-17 years. Must be <18 prior to injection.
- •>10 kilograms at screening and injection visits
- •Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy
- •Gross Motor Function Classification System level: I, II, III
- •Ability to ambulate independently without aid, equinus gait
- •Absent of joint or bone deformities
- •Eligible to receive single-event multi-level chemoneurolysis (SEMLC)
- •Cooperative and tolerant to testing procedures during clinic screening
- •Presence of spasticity in one or both legs
- •Be on a stable dose and regimen if on any prescribed medication/s
- •Parent must have signed written informed consent and the Patient Authorization for Use and Release of Health and Research Study Information
排除标准
- •Ankle contractures no more than -10 degrees with the knee extended
- •Hemiplegia
- •Wheelchair dependent
- •Received Botulinum toxin within previous 4 months
- •Uncontrolled epilepsy or certain types of seizures
- •Fracture in the study limb within previous 12 months
- •Infection or skin disorder at planned injection site
- •Shortness of breath or other respiratory issues
- •Uncontrolled clinically significant medical condition
- •Received phenol or alcohol block in the study limb within previous 6 months
- •Surgery in the study limb within previous 12 months
- •Serial casting within previous 12 months
- •New physiotherapy and/or orthotic regimen <1 month before study start. (physiotherapy and/or orthotic regimen will be permitted if it began >1 month before study start and maintained throughout study)
研究组 & 干预措施
Dysport Injectable Product
All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.
干预措施: Dysport Injectable Product (Drug)
结局指标
主要结局
Oxygen Consumption (ml/kg/Min)
时间窗: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection
Energy expenditure (oxygen consumption (VO2)) will be measured during the 6 minute walk test using a portable metabolic cart. The participants will use a 10 meter walkway to walk back and forth during the 6 minutes to coverage as much distance as possible. During this time they will be wearing a portable spirometric device that collects the oxygen consumption (VO2) per minute.
次要结局
- Gait Velocity (cm/s)(Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection)
- Muscle Spasticity Using MTS(Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection)
- Score on the Cerebral Palsy Quality of Life (CP QOL) Questionnaire(Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection)
- Muscle Spasticity Using MAS(Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection)