Collagenase Injection for Contracture and Spasticity Management
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
研究概览
简要总结
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for spasticity management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
排除标准
- •Is hypersensitive to XIAFLEX or collagenase;
- •Is currently adjusting tone alternating medications (e.g., baclofen), or
- •Received botulinum toxin injection to target areas <4 months, or phenol injections < 9 months;
- •Received surgical release of tendons;
- •Is a pregnant woman;
- •Has coagulation disorders, including those who receive concomitant anticoagulants (except for low-dose aspirin).
- •has heritable connective tissue disorders, including those within the Ehlers-Danlos syndrome (EDS) spectrum.
结局指标
主要结局
Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
时间窗: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
The Modified Ashworth Scale (MAS) evaluates the increase in muscle tone associated with upper motor neuron lesions. MAS scores will be recorded for the target muscle group(s) at each assessment time point.Scores range from 0 to 4, with an additional grade of 1+ between 1 and 2. Scores are defined as: 0 = no increase in muscle tone; 1 = slight increase in muscle tone with a catch and release or minimal resistance at the end of the range of motion; 1+ = slight increase in muscle tone with a catch followed by minimal resistance through less than half of the range of motion; 2 = more marked increase in muscle tone through most of the range of motion, but the affected part is easily moved; 3 = considerable increase in muscle tone, passive movement difficult; 4 = affected part rigid in flexion or extension.Lower MAS scores indicate reduced spasticity and improved muscle tone, whereas higher scores indicate greater spasticity.
Safety as assessed by the number of adverse events
时间窗: From baseline to end of study (3 months post-injections)
Adverse events include 1. Serious complications of XIAFLEX injection include tendon rupture, serious ligament damage, or skin laceration that may result in the inability to fully bend the joint and may require surgery to correct the complication. 2. XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.
次要结局
- Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)(Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections)
- Change in range of motion of target joints as assessed by the Active Range of Motion (AROM)(Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections)
研究者
Sheng Li
Professor
The University of Texas Health Science Center, Houston