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

Primary Purpose

Stroke, Muscle Spasticity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Optimal muscle activation therapy
Standard Therapy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Botulinum Toxin, Rehabilitation, Electromyography, Electroencephalography, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

Optimal Muscle Activation Therapy

Arm Description

Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Motor Evoked Potential amplitude
To measure the change in cortical excitability associated with the intervention.
Goal Attainment Scale
Change in Goal Attainment Scale
Modified Ashworth Scale
Change in Modified Ashworth Scale
Modified Tardieu Scale
Change in Modified Tardieu Scale
Frequency and amplitude of electroencephalographic (EEG) activity
Measurement of event-related cortical activity

Full Information

First Posted
December 13, 2012
Last Updated
May 19, 2015
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01751373
Brief Title
Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
Official Title
Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Muscle Spasticity
Keywords
Botulinum Toxin, Rehabilitation, Electromyography, Electroencephalography, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
Arm Title
Optimal Muscle Activation Therapy
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Optimal muscle activation therapy
Other Intervention Name(s)
Botulinum Toxin-A, Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Therapy
Primary Outcome Measure Information:
Title
Amplitude and timing of electromyographic signals (EMG)
Description
Change in electrical activation patterns of the target muscle(s) (i.e. muscle receiving BTX injection) and the antagonist muscle.
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Secondary Outcome Measure Information:
Title
Motor Evoked Potential amplitude
Description
To measure the change in cortical excitability associated with the intervention.
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Title
Goal Attainment Scale
Description
Change in Goal Attainment Scale
Time Frame
Baseline, 6 Months
Title
Modified Ashworth Scale
Description
Change in Modified Ashworth Scale
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Title
Modified Tardieu Scale
Description
Change in Modified Tardieu Scale
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Title
Frequency and amplitude of electroencephalographic (EEG) activity
Description
Measurement of event-related cortical activity
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Mochizuki, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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