Trial - TRAIL
Contact information for trial coordinators and research leaders is available here: http://canadianstroke.ca/sites/default/files/inline-files/CanStroke.pdf
CPSR researchers have received funding from the Canadian Institutes of Health Research (CIHR) and Canadian Medical Association (CMA) to conduct a three-year, six-site randomized controlled trial (RCT) into the effectiveness of a telerehabilitation program to improve walking, balance and self-management after stroke.
TRAIL (TeleRehabilitation with Aims to Improve Lower extremity recovery poststroke) will recruit 96 people in Halifax, Toronto, London, Winnipeg, Vancouver and Kelowna. CIHR is contributing $279K to the trial and $75K is coming from the CMA as part of an effort to advance virtual care. The trial is expected to roll out this fall on the CanStroke Recovery Trials platform.
CanStroke is the only clinical trials platform of its kind in the world focused on stroke recovery.
Dr. Brodie Sakakibara of UBC-Okanagan and Dr. Ada Tang of McMaster University will direct the research effort, which builds on a proof-of-concept study conducted during the Covid-19 pandemic. “We wouldn’t have been successful in getting this grant if it wasn’t for the pilot data gathered on CanStroke Recovery Trials platform,” Dr. Tang says.
The idea for TRAIL began in 2019 when Dr. Janice Eng of UBC and Dr. Mark Bayley of Toronto Rehab, both leaders of the CanStroke Recovery Trials platform, first suggested leveraging Dr. Tang’s expertise in exercise and Dr. Sakakibara’s expertise in telerehab and self-management to develop a program to extend virtual rehabilitation to people with lower-limb impairment after stroke.
TRAIL is a four-week, eight-session program of progressive exercise and self-management support delivered via video-conferencing by trained telerehabilitation therapists.
Earlier this year, after completing a proof-of-concept trial involving 32 participants, the Sakakibara-Tang team secured $100K in CIHR funds for a one-year pilot study of the TRAIL program. Additional CIHR funds will now be used to scale up the pilot study into a full trial, led by McMaster PhD candidate Elise Wiley. Sarah Park of UBC worked on the feasibility phase of the study as part of her MSc. The RCT will also continue to have a strong training component.
Many people recovering from stroke receive minimal to no follow-up rehabilitation after returning to the community. They commonly report unmet rehabilitation needs, particularly for recovery of walking and balance. As a result, effective and accessible community-based programs are needed to extend rehabilitation beyond the hospital setting.
Rapid growth in Internet use and personal mobile technologies has opened an array of possibilities to deliver rehabilitation to people in their homes and communities. However, there is a lack of research into telerehabilitation for the delivery of physical interventions focused on lower extremities.
In the upcoming RCT, participants will be randomized into TRAIL, which focuses on exercise and self-management support, or a group that focuses on education of cardio-metabolic and behavioural risk factors known to affect health.
The multi-site RCT will compare functional mobility between stroke survivors in TRAIL and those in the attention-controlled stroke education program. The trial will compare lower extremity muscle strength, motor impairment, functional balance, balance self-efficacy, and health-related quality of life between TRAIL and education participants; and compare health service use and associated costs between TRAIL and participants in the education group.
The end goal is to inform best practices in virtual care and have widespread application in practice when access to in-person rehabilitation is not feasible, such as in rural, remote and underserviced areas, or when physical-distancing measures are needed.
Recent results of surveys conducted by the BC Primary Health Care Network (https://physiotherapy.ca/covid-19-quick-canadian-physiotherapist-survey-wave-2) and the Ontario Physiotherapy Association (https://opa.on.ca/wp-content/uploads/2020/08/Telerehab-in-Physiotherapy-During-COVID-19-Pandemic-Survey-Report.pdf) indicate that upwards of 94% of physical therapists transitioned to tele-rehabilitation during COVID-19, and that as many as 84% will continue using tele-rehabilitation after the end of the pandemic. Considering these findings, research to develop evidence-based tele-rehabilitation programs for clinical use and to optimize the delivery of tele-rehabilitation is increasingly important.
To learn more about TRAIL, visit https://blogs.ubc.ca/trailstudy/