Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
- Conditions
- StrokeMuscle Spasticity
- Interventions
- Behavioral: Standard TherapyBehavioral: Optimal muscle activation therapy
- Registration Number
- NCT01751373
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- >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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard Therapy Standard Therapy Coupling focal BoNT-A injections with a therapy program comprising of functional tasks. Optimal Muscle Activation Therapy 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.
- Primary Outcome Measures
Name Time Method Amplitude and timing of electromyographic signals (EMG) 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.
- Secondary Outcome Measures
Name Time Method Modified Ashworth Scale Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 Change in Modified Ashworth Scale
Modified Tardieu Scale Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 Change in Modified Tardieu Scale
Frequency and amplitude of electroencephalographic (EEG) activity Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 Measurement of event-related cortical activity
Motor Evoked Potential amplitude Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 To measure the change in cortical excitability associated with the intervention.
Goal Attainment Scale Baseline, 6 Months Change in Goal Attainment Scale
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada