March 20, 2020

As Canada and other countries deal with the urgent health and economic impact from the COVID-19 pandemic, research institutes are likewise trying to deal with the impact on research activities. In line with directives from Health Canada and our participating research institutes, the eight-site CanStroke Recovery Platform, funded through a grant from Brain Canada and CPSR, is suspending enrollment for the ongoing FLOW Trial and delaying the start-up or expansion of four more planned trials in stroke recovery. However, participants already enrolled in a trial are currently being allowed to continue participation at some institutions (but that too could change as this crisis is evolving on a daily basis).  

While enrollment in clinical trials is on hold, all sites are still actively looking for potential participants. The hope is, once the ban is lifted, identified potential participants could be screened for the FLOW trial, 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, 338 people were identified for participation in the FLOW trial, 75 made it to the consent phase and 46 made it to the drug ramp-up phase and were moving into the 12-week exercise intervention phase, and four have made it to the six-month assessment phase.

Josie Chundamala at UHN is project manger of CanStroke Recovery Platform. There are trial coordinators and principal investigators at each site.

Four more studies had been identified for the CanStroke Recovery Platform and will continue when research efforts begin to ramp up again. They include Arm Boot Camp (ABC), led by Dr. Janice Eng at UBC, at four 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. Mark Bayley at Toronto Rehab 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, 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."

To learn more about CanStroke Recovery Platform, contact Josie at the link attached to her name, above. She can answer your questions and put you in touch with site coordinators.

All across Canada, researchers are being impacted by the COVID-19 pandemic as studies are suspended to prevent the spread of the virus. It is unclear what the full impact will be on ongoing research efforts and how funding agencies and the federal government will adjust financial or progress reporting or extend research efforts underway. CIHR recently released a statement acknowledging the impact of the crisis on research studies and funding competitions, as well as their commitment for action to help the research community.