Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
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|ClinicalTrials.gov Identifier: NCT01751373|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : May 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Muscle Spasticity||Behavioral: Optimal muscle activation therapy Behavioral: Standard Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
Behavioral: Standard Therapy
Experimental: 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.
Behavioral: Optimal 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.
- Amplitude and timing of electromyographic signals (EMG) [ Time Frame: 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.
- Motor Evoked Potential amplitude [ Time Frame: 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 [ Time Frame: Baseline, 6 Months ]Change in Goal Attainment Scale
- Modified Ashworth Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ]Measurement of event-related cortical activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751373
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||George Mochizuki, PhD||Sunnybrook Health Sciences Centre|