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

NCT ID: NCT01751373

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Stroke; Muscle Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Therapy

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

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Optimal muscle activation therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard Therapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Botulinum Toxin-A; Therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. George Mochizuki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Mochizuki, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

ALSRIIIT-01

Identifier Type: -

Identifier Source: org_study_id