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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started May 2011
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 20, 2015
May 1, 2015
3.5 years
December 13, 2012
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amplitude and timing of electromyographic signals (EMG)
Change in electrical activation patterns of the target muscle(s) (i.e. muscle receiving BTX injection) and the antagonist muscle.
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Secondary Outcomes (5)
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
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
Study Arms (2)
Standard Therapy
ACTIVE COMPARATORCoupling focal BoNT-A injections with a therapy program comprising of functional tasks.
Optimal Muscle Activation Therapy
EXPERIMENTALCoupling focal BoNT-A injections with a motor training program that focuses on developing and maintaining activation patterns in the muscle treated with BoNT-A.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Allergancollaborator
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Mochizuki, PhD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 13, 2012
First Posted
December 18, 2012
Study Start
May 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 20, 2015
Record last verified: 2015-05