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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Stroke; Muscle Spasticity

Treatments: Behavioral: Standard Therapy; Behavioral: Optimal muscle activation therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01751373

ALSRIIIT-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Therapy

Optimal Muscle Activation Therapy

Experimental group

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.

Treatment:

Behavioral: Optimal muscle activation therapy