- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01751373
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
|
|
|
Eksperimentell: 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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Amplitude and timing of electromyographic signals (EMG)
Tidsramme: 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.
|
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor Evoked Potential amplitude
Tidsramme: 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.
|
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
|
Goal Attainment Scale
Tidsramme: Baseline, 6 Months
|
Change in Goal Attainment Scale
|
Baseline, 6 Months
|
|
Modified Ashworth Scale
Tidsramme: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Change in Modified Ashworth Scale
|
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
|
Modified Tardieu Scale
Tidsramme: 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
|
|
Frequency and amplitude of electroencephalographic (EEG) activity
Tidsramme: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Measurement of event-related cortical activity
|
Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: George Mochizuki, PhD, Sunnybrook Health Sciences Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Muskel- og skjelettsykdommer
- Muskelsykdommer
- Nevromuskulære manifestasjoner
- Muskelhypertoni
- Slag
- Muskelspastisitet
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylkolinfrigjøringshemmere
- Nevromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
Andre studie-ID-numre
- ALSRIIIT-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .