Muscle Spasticity, Stroke
Conditions
Keywords
Botulinum Toxin, Rehabilitation, Electromyography, Electroencephalography, Transcranial Magnetic Stimulation
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.
Interventions
BEHAVIORALOptimal muscle activation therapy
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.
BEHAVIORALStandard Therapy
Sponsors
Allergan
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale | Baseline, 6 Months | Change in Goal Attainment Scale |
| 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. |
| 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 |
Countries
Canada
Outcome results
None listed