Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A
Within the first year after stroke, approximately 38% of stroke survivors experience an increased resistance to movement, also called spasticity. One type of treatment that is approved for stroke survivors in Canada that could reduce spasticity is the injection of Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is limited evidence to show that BTX administration leads to functional improvements. This may occur because the outcomes aren't sensitive enough to detect change, some people may have better responses to BTX, or because BTX hasn't been paired with the right exercises to improve function. The aims of this research are: i) to determine if there is a way of improving the markers that measure change in response to treatment; and ii) to identify the ideal type of exercise that should be paired with BTX to allow the drug to have it greatest effect.
There are two primary research questions: a) What are the measures that will indicate whether a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that EMG latency and amplitude, for those who best respond to BTX, will differ from those who demonstrate a weaker response to BTX; b)What is the ideal training approach for improving muscle function in stroke survivors receiving BTX injections? It is hypothesized that a training protocol that focuses on optimizing specific muscle activation patterns will demonstrate better outcomes than a training program designed to improve function.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Health Sciences Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- >120 days post first ischemic stroke
- Unilateral spasticity (MAS ≥ 1) of the wrist or elbow
- >18 years of age
- Medical referral for focal BoNT-A injections
- Residual active control of the wrist or elbow
Exclusion Criteria:
- Underlying neuromuscular disorders (i.e. ALS, neuropathies, myasthenia gravis)
- Inability to provide informed consent or communicate in English
- Bilateral paresis/spasticity
- Contractures
- Prescribed anti-spastic medication
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
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|
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实验性的:Optimal Muscle Activation Therapy
Coupling focal BoNT-A injections with a motor training program that focuses on developing and maintaining activation patterns in the muscle treated with BoNT-A.
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The proposed study uses a longitudinal, within-subject, pre/post intervention, cross-over design.
All participants will complete each of 4 study phases (each 12 weeks long).
These include: a) focal BTX injections in combination with either Standard Therapy or Optimal Muscle Activity Therapy; b) a three-month period where no treatment is given; c) focal BTX injections in combination either Standard Therapy or Optimal Muscle Activation Therapy; d) another three-month period where no treatment is given.
The order of treatment phases will be counter-balanced across participants.
其他名称:
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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 |
|---|---|---|
|
Amplitude and timing of electromyographic signals (EMG)
大体时间:Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in electrical activation patterns of the target muscle(s) (i.e.
muscle receiving BTX injection) and the antagonist muscle.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Motor Evoked Potential amplitude
大体时间:Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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To measure the change in cortical excitability associated with the intervention.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
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Goal Attainment Scale
大体时间:Baseline, 6 Months
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Change in Goal Attainment Scale
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Baseline, 6 Months
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Modified Ashworth Scale
大体时间:Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in Modified Ashworth Scale
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Modified Tardieu Scale
大体时间:Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in Modified Tardieu Scale
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
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Frequency and amplitude of electroencephalographic (EEG) activity
大体时间:Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Measurement of event-related cortical activity
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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合作者和调查者
合作者
调查人员
- 首席研究员:George Mochizuki, PhD、Sunnybrook Health Sciences Centre
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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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