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Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751373
First Posted: December 18, 2012
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Dr. George Mochizuki, Sunnybrook Health Sciences Centre
December 13, 2012
December 18, 2012
May 20, 2015
May 2011
November 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01751373 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Stroke
  • Muscle Spasticity
  • 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.
    Other Names:
    • Botulinum Toxin-A
    • Therapy
  • Behavioral: Standard Therapy
  • Active Comparator: Standard Therapy
    Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
    Intervention: 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.
    Intervention: Behavioral: Optimal muscle activation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01751373
ALSRIIIT-01
No
Not Provided
Not Provided
Dr. George Mochizuki, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Allergan
Principal Investigator: George Mochizuki, PhD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP