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Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
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Experimenteel: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Amplitude and timing of electromyographic signals (EMG)
Tijdsspanne: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in electrical activation patterns of the target muscle(s) (i.e.
muscle receiving BTX injection) and the antagonist muscle.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Motor Evoked Potential amplitude
Tijdsspanne: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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To measure the change in cortical excitability associated with the intervention.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
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Goal Attainment Scale
Tijdsspanne: Baseline, 6 Months
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Change in Goal Attainment Scale
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Baseline, 6 Months
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Modified Ashworth Scale
Tijdsspanne: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Change in Modified Ashworth Scale
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Modified Tardieu Scale
Tijdsspanne: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Change in Modified Tardieu Scale
|
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Frequency and amplitude of electroencephalographic (EEG) activity
Tijdsspanne: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Measurement of event-related cortical activity
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: George Mochizuki, PhD, Sunnybrook Health Sciences Centre
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neurologische manifestaties
- Musculoskeletale aandoeningen
- Spierziekten
- Neuromusculaire manifestaties
- Spier hypertonie
- Hartinfarct
- Spier spasticiteit
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Cholinerge middelen
- Membraantransportmodulatoren
- Acetylcholine-afgifteremmers
- Neuromusculaire middelen
- Botulinetoxinen
- Botulinetoxinen, Type A
Andere studie-ID-nummers
- ALSRIIIT-01
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