CanStroke Recovery Trials is an eight-site national clinical trials platform in stroke recovery, funded by Brain Canada and CPSR. It brings together the leading clinicians and researchers across Canada to test new approaches, therapies, therapeutics and technologies to improve recovery from stroke.
Dr. Mark Bayley, Toronto Rehabilitation Institute (Mark.Bayley@uhn.ca)
Dr. Janice Eng, University of British Columbia (email@example.com)
Farrell Leibovitch, CPSR (firstname.lastname@example.org)
Dr. Sean Dukelow, University of Calgary, Hotchkiss Brain Institute (email@example.com)
Dr. Marilyn Mackay-Lyons, Dalhousie University (firstname.lastname@example.org)
Dr. Robert Teasell, Western University (email@example.com)
Dr. Michelle Ploughman, Memorial University of Newfoundland (Michelle.Ploughman@med.mun.ca)
Dr. Sandra Black, Sunnybrook Health Sciences, (firstname.lastname@example.org)
Dr. Bradley MacIntosh, Sunnybrook Health Sciences (email@example.com)
Dr. Courtney Pollock, University of British Columbia (firstname.lastname@example.org)
Dr. Sepideh Pooyania, Riverview Health Centre, Manitoba (email@example.com)
While enrolment in some clinical trials is temporarily on hold during the Covid-19 pandemic, all CanStroke Recovery Trials sites are still actively looking for potential participants. Two studies, ABC and TRAIL (see details below), have been converted to completely remote trials so they can run during the pandemic.
The hope is, once restrictions put in place during the pandemic are lifted, identified potential participants can be screened for all CanStroke trials.
These include the first CanStroke trial, called FLOW, which involves a 'combination approach' -- the anti-depressant drug fluoxetine and exercise -- aimed at reopening the window of recovery for people with chronic stroke.
Since initiating recruitment in January 2019, 346 people were identified for participation in the FLOW trial, 76 made it to the consent phase and 47 made it to the drug ramp-up phase and were moving into the 12-week exercise intervention phase, and five have made it to the six-month assessment phase.
Four more studies have been identified for the CanStroke Recovery Platform and will continue when research efforts begin to ramp up again.
- Arm Boot Camp (ABC), led by Dr. Janice Eng at UBC, at seven platform sites. ABC will determine the feasibility of a treatment program that involves feedback from a wearable device in combination with an exercise program. It will determine the effect it has on the amount of stroke-affected upper limb use.
- Dr. Sean Dukelow's RESTORE trial compares two intensities of robotic therapy for rehabilitation. It will be rolled out at the Calgary and UHN sites.
- Five of the 8 platform sites will participate in the TRAIL trial. TRAIL (TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke) is led by Dr. Brodie Sakakibara at UBC and Dr. Ada Tang at McMaster and will examine the feasibility of a lower extremity telerehabilitation protocol among community-living stroke survivors, and the effectiveness of a telerehab protocol on functional mobility and lower-extremity impairment.
- And, finally, a TMS add-on study will become part of the FLOW trial, looking at the added value of brain stimulation in the combination-therapy approach.
Once things return to normal, CanStroke Recovery Trials project manager Josie Chundamala said new trials will be able to move along much more quickly because the platform is in place, training has been done, site agreements and data transfer agreements are in place, and the CanStroke Recovery Platform has made it easier and faster to get things up and running. "There is an efficient process," she said. "We know the steps involved."
Full details about who is involved in CanStroke and contact information for each project can be found HERE.
Meet a Trial Participant
Debbie Tompkins, Halifax
A camping trip to New Brunswick with her six grandchildren seemed like the perfect way to mark a new phase of life last summer for recently retired nurse Debbie Tompkins.
Until, days before the planned departure, a stroke changed everything.
Signs of stroke began slowly. Her right leg felt unhinged. The 63-year-old Halifax woman went to the hospital and, although she felt no pain, received a diagnosis of sciatica, or nerve pain.
The next day, a Monday, she could barely walk. By Tuesday, she was back at the emergency department. Again, she returned home – no CT scan, no MRI, but with a plan to consult a neurologist.
The week dragged on. Sometimes she could put weight on her leg and sometimes she couldn’t. When she awoke on Sunday morning – a week to the day after her first hospital visit – she was nauseated and perspiring. She called 9-1-1.
“It was too late to get a clot-busting drug” to reverse the stroke symptoms at the hospital, but she was put on blood thinners. “Women are underdiagnosed, not listened to, and present differently,” she says.
Debbie moved from acute care to an inpatient stroke rehabilitation unit and stayed there until the end of October.
While in the inpatient rehab unit, Debbie was recruited to participate in CPSR’s FLOW trial -- the first national trial on the CanStroke Recovery Trials platform. It combines intensive rehabilitation therapy with the drug fluoxetine in an effort to enhance post-stroke recovery.
For Debbie, her participation meant an additional 12 weeks of therapy she would not have had otherwise.
“I’ve really enjoyed the FLOW,” Debbie says. “It’s hard and I’m exhausted when I’m done, but it’s good.”
For her, there is no question that extra therapy provided from her involvement in CanStroke Recovery Trials put her back on the road to recovery – and rekindling her camping plans.
Meet three of our CanStroke Trials Coordinators
Some of CanStroke Recovery Trials's amazing coordinators: From left, Evan Foster in Toronto, Mitch Longval in London, and Maria Williams in St. John's.
CanStroke Recovery Trials Coordinators focus on individuals, target the greater good
CanStroke Recovery Trials is a platform to test, scale up and fast-track new ideas. Research leaders bring their expertise to advance the field and, at each of the eight sites, coordinators pull the pieces together to get the trials underway.
What does the job of a CanStroke Recovery Trials coordinator entail? They follow a rigorous approval process for safety and ethics at their sites. They stickhandle subsite and legal agreements. They help identify people to participate in trials (sometimes cold-calling patients to ask them to get involved). Coordinators ensure people get the necessary screening and assessments – bloodwork to measure electrolytes and platelet counts for safety; genetic tests to identify biomarkers; brain scans to characterize the location of the stroke and the size of the lesion; as well as heart monitoring, and cognitive and fitness testing. These days, coordinators also have to screen participants for Covid-19.
After the workup, each of the coordinators meet with supervising clinicians to determine an individual’s eligibility for trial participation. Through it all, there is constant communication between the coordinator and the participant. From the participant’s perspective, involvement in CanStroke Recovery Trials means special attention, extended access to post-stroke therapy, and the knowledge that their participation in research will improve recovery for others.
Evan Foster is the CanStroke Recovery Trials coordinator at Toronto Rehab/University Health Network. Foster, who is doing a Master’s degree at the University of Toronto in translational research, has been involved in CanStroke since the beginning – and even co-authored a poster for the 2019 Canadian Stroke Congress on the ‘trials and tribulations’ of setting up a clinical trials network in stroke recovery in Canada.
These days he is wrapping up the FLOW trial, which tests a combination of exercise and drug therapy to reopen the recovery window after stroke. He is also ramping up TRAIL, which delivers in-home virtual therapy to people with lower-limb impairment. And, he is working on Arm Boot Camp (ABC), a trial that focuses on delivering therapy to stroke-affected arms.
Foster says the best part about being a CanStroke Recovery Trials coordinator is building relationships, “being able to help somebody and being able to see their improvement after stroke.” After participating in one trial, many participants take a strong interest in research and subsequently enroll in other trials. The hardest part of the job of a coordinator is telling someone they don’t meet the criteria to take part in a trial.
Mitch Longval, CanStroke Recovery coordinator at Lawson Research Institute and St. Joseph’s Health Care in London, says he, too, enjoys “interacting with the participants and hearing about their experiences and how we can help them.” The job’s biggest challenge? “Trying to keep on top of all the moving parts of all the different trials.”
He sees a huge value in being part of a trials platform, where he can get support, advice and guidance from other coordinators and site leaders in the network. “The platform has been helpful in so many ways,” Longval says. “You always have help at your fingertips. Being able to run multi-centre studies would be such a huge task without a platform like this.”
Maria Williams, a physiotherapist with a research background, is CanStroke Recovery Trials coordinator at LA Miller Centre in St. John’s, NL. She disseminates information about the CanStroke studies, attends rounds on the stroke unit once a week to help identify people who could be candidates for trials, hands out information and answers questions. After developing an initial list of participants, Williams follows up in person or on the phone before starting the consent process and getting paperwork in place.
Because she’s a clinician, a typical day might involve doing a baseline assessment of a potential participant, conducting an exercise session with a study participant, dispensing and tracking medication, setting up follow-up sessions, and ordering assessments and bloodwork. “I like the variety. I have a lot of things coming at me every day and I like the challenge,” she says.
“People are quite pleased and excited to have CanStroke Recovery Trials available here in Newfoundland,” Williams explains. “I have one gentleman who moved from the other side of the island to participate in a trial.” Like the other coordinators, she feels grateful to be part of a platform that provides so much support to all sites across the country – from answering questions to data management to site monitoring. “You don’t feel like you’re on your own trying to figure things out.”
But her favourite part of the job is meeting the participants. “Every single individual and stroke is different.”