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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01751373

Collaborator

Allergan (Industry)

Enrollment

Location

Arms

42.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Muscle Spasticity	Behavioral: Optimal muscle activation therapy Behavioral: Standard Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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. Other Names: Botulinum Toxin-A Therapy

Arm

Intervention/Treatment

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.

Other Names:

Botulinum Toxin-A

Therapy

Outcome Measures

Primary Outcome Measures

Amplitude and timing of electromyographic signals (EMG) [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 Outcome Measures

Motor Evoked Potential amplitude [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 [Baseline, 6 Months]
Change in Goal Attainment Scale
Modified Ashworth Scale [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 [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 [Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12]
Measurement of event-related cortical activity