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Completed

NCT Number: NCT01751373

Assessment and Management of 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimal muscle activation therapy

Behavioral

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

Standard Therapy

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Goal Attainment Scale

    Time frame: Baseline, 6 Months

    Change in Goal Attainment Scale

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Allergan

Registry information

Official study title

Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 18, 2012
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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