Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Amplitude and timing of electromyographic signals (EMG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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
研究组 & 干预措施
Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
干预措施: Standard Therapy (Behavioral)
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.
干预措施: Optimal muscle activation therapy (Behavioral)
结局指标
主要结局
Amplitude and timing of electromyographic signals (EMG)
时间窗: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Change in electrical activation patterns of the target muscle(s) (i.e. muscle receiving BTX injection) and the antagonist muscle.
次要结局
- Modified Ashworth Scale(Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12)
- Modified Tardieu Scale(Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12)
- Frequency and amplitude of electroencephalographic (EEG) activity(Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12)
- Motor Evoked Potential amplitude(Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12)
- Goal Attainment Scale(Baseline, 6 Months)
研究者
Dr. George Mochizuki
Principal Investigator
Sunnybrook Health Sciences Centre
