Vincent Thijs (Australia)
Florey Institute of Neuroscience and Mental Health Stroke ThemeAuthor Of 2 Presentations
UPPER LIMB THERAPY DURING THE FIRST 6-MONTHS AFTER STROKE: A SYSTEMATIC REVIEW OF TIMING, DOSE, AND EFFICACY.
Abstract
Background and Aims
Early and intense motor intervention is thought to yield greater upper limb recovery post-stroke. This systematic review investigated timing, dose and efficacy of upper limb intervention during the first 6-months post-stroke.
Methods
Three databases were searched (PROSPERO:CRD42016048035). Studies that enrolled people ≤6-months post-stroke, aimed to improve upper limb recovery, and completed pre- and post-intervention assessment were included. Studies were examined by timing (recovery epoch), dose and efficacy (minimal clinical important difference, MCID).
Results
261 studies were included, representing 228 (n=9,704 participants) unique datasets. Studies per 5-year interval increased from one (n=37 participants) between 1980-1984 to 91 (n=4,417 participants) between 2015-2019. Participants were enrolled a median 38 days (IQR 22-66) post-stroke. Studies were identified within each recovery epoch: 1 hyperacute, 13 acute, 176 early subacute, 34 late subacute; 4 unable to be categorised. The median intervention and control dose was 45-minutes/session, 1 session/day, 5-days/week for 4-weeks, which was consistent across epochs. For motor impairment, 102 studies contained data to interpret a MCID. In 69% (n=70) of these studies, impairment outcomes were similar (eg. MCID achieved by intervention and control groups). For motor activity, 107 studies contained data to interpret a MCID and 67% (n=72) of activity outcomes were similar.
Conclusions
Despite a large and growing body of research, lack of consistent data elements prevented identification of the optimal timing to commence upper limb intervention post-stroke, and the effect of timing and dose on efficacy. A united research agenda that establishes a biological understanding of timing and dose is needed to progress stroke recovery research.
ONGOING CLINICAL TRIAL: A PROSPECTIVE MULTICENTRE, PHASE 2B RANDOMISED, CONTROLLED DOUBLE-BLIND TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF PERISPINAL ETANERCEPT ON QUALITY OF LIFE
Abstract
Background and Aims
There are few treatment options for stroke survivors with ongoing impairments. Recently, the beneficial effects of a tumor necrosis factor inhibitor, etanercept, has caught the attention of the media and the stroke survivor community. Observational, uncontrolled studies suggest substantial improvements of chronic impairments after a single administration of etanercept, injected subcutaneously in the perispinal region. Large, randomized controlled trials have not been conducted.
Methods
The Perispinal Etanercept for STroke Outcomes trial (ACTRN12620001011976) is a 30-months, phase 2b, multicenter, randomized, double blind, placebo-controlled trial testing the safety and efficacy of administration of perispinal etanercept in improving patient reported outcomes at 28 days after treatment. The required sample size is 168. Eligible patients are aged ≤65 years at time of stroke, between 1-5 year after the index stroke, with a current modified Rankin scale of 3 to 5. The primary efficacy hypothesis is that treatment with perispinal etanercept improves quality of life in stroke survivors, as measured with the Short Form-36. The secondary hypothesis is that repeated injection of etanercept leads to improved quality of life compared to a single injection. Other exploratory outcome measures include the NIHSS, MOCA, FIM, modified Rankin scale, pain VAS, FAS, PHQ-9, GAD-7.
Results
The trial is ongoing with 36 patients enrolled as of May 14 2021 at sites in Australia and New Zealand.
Conclusions
The promise of etanercept to improve quality of life in chronic stroke survivors needs to be tested. PESTO will inform the stroke community about the efficacy and safety of this intervention.
Presenter of 1 Presentation
ONGOING CLINICAL TRIAL: A PROSPECTIVE MULTICENTRE, PHASE 2B RANDOMISED, CONTROLLED DOUBLE-BLIND TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF PERISPINAL ETANERCEPT ON QUALITY OF LIFE
Abstract
Background and Aims
There are few treatment options for stroke survivors with ongoing impairments. Recently, the beneficial effects of a tumor necrosis factor inhibitor, etanercept, has caught the attention of the media and the stroke survivor community. Observational, uncontrolled studies suggest substantial improvements of chronic impairments after a single administration of etanercept, injected subcutaneously in the perispinal region. Large, randomized controlled trials have not been conducted.
Methods
The Perispinal Etanercept for STroke Outcomes trial (ACTRN12620001011976) is a 30-months, phase 2b, multicenter, randomized, double blind, placebo-controlled trial testing the safety and efficacy of administration of perispinal etanercept in improving patient reported outcomes at 28 days after treatment. The required sample size is 168. Eligible patients are aged ≤65 years at time of stroke, between 1-5 year after the index stroke, with a current modified Rankin scale of 3 to 5. The primary efficacy hypothesis is that treatment with perispinal etanercept improves quality of life in stroke survivors, as measured with the Short Form-36. The secondary hypothesis is that repeated injection of etanercept leads to improved quality of life compared to a single injection. Other exploratory outcome measures include the NIHSS, MOCA, FIM, modified Rankin scale, pain VAS, FAS, PHQ-9, GAD-7.
Results
The trial is ongoing with 36 patients enrolled as of May 14 2021 at sites in Australia and New Zealand.
Conclusions
The promise of etanercept to improve quality of life in chronic stroke survivors needs to be tested. PESTO will inform the stroke community about the efficacy and safety of this intervention.