Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Bruna de Oliveira, MD
- 电话号码:5521999200801
- 邮箱:b_andrade@id.uff.br
学习地点
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Rio de Janeiro
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Rio de Janeiro、Rio de Janeiro、巴西、22290-140
- 招聘中
- Instituto de Neurologia Deolindo Couto
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接触:
- Bruna de Oliveira
- 电话号码:5521999200801
- 邮箱:b_andrade@id.uff.br
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria
- Age over 18 years
- Clinical diagnosis of spastic paraplegia
- Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
- Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
- Enrollment in a rehabilitation program
- For women of childbearing potential, a negative beta-hCG test at the time of injection
Exclusion Criteria
- Concomitant neuromuscular disorders
- History of hypersensitivity to botulinum toxin
- Active infection at the injection site
- Ashworth Scale score of 4
- Pregnancy or breastfeeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)
Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period: First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique. Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique |
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization.
Performed 16 weeks after the first intervention.
Assessments are performed pre-injection and 4 weeks post-injection
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation.
Assessments are performed at baseline and 4 weeks post-injection.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in spasticity after BoNT-A injection techniques
大体时间:Baseline and 4 weeks after each injection session
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Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia.
The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)
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Baseline and 4 weeks after each injection session
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Functional improvement assessed by Goal Attainment Scaling
大体时间:Baseline and 4 weeks after each intervention
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Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome) |
Baseline and 4 weeks after each intervention
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Functional mobility assessed by the Timed Up and Go Test
大体时间:Baseline and 4 weeks after each intervention
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Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome) |
Baseline and 4 weeks after each intervention
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Change in functional independence assessed by the Modified Barthel Index
大体时间:Baseline and 4 weeks after each intervention
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Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome). |
Baseline and 4 weeks after each intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensity after BoNT-A injection techniques
大体时间:Baseline and 4 weeks after each intervention
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Change in pain intensity measured by the Visual Analog Scale (VAS).
The Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcome)
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Baseline and 4 weeks after each intervention
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Quality of life after BoNT-A injection techniques
大体时间:Baseline and 4 weeks after each intervention
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Change in quality of life assessed by the 36-Item Short Form Health Survey (SF-36). The SF-36 assesses eight health domains, with scores ranging from 0 to 100 for each domain. Higher scores indicate better health status (better outcome) |
Baseline and 4 weeks after each intervention
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Adverse events related to BoNT-A injection techniques
大体时间:Up to 16 weeks after each injection
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Incidence and severity of adverse events associated with conventional landmark-guided and ultrasound-guided botulinum toxin type A injections
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Up to 16 weeks after each injection
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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