FLOW Trial: FLuoxetine to Open the critical time period Window to improve motor recovery after stroke
Toronto Rehabilitation Institute (KITE) - University Health Network, Mobility
The FLOW trial will evaluate the effect of combining an antidepressant (e.g. fluoxetine, known more commonly as Prozac) with exercise rehabilitation across multiple Canadian sites in 176 stroke patients. Fluoxetine has been shown in animal models to keep open the period of recovery post-stroke. The trial rationale is that motor function will be significantly improved by pairing fluoxetine with a task-based exercise program. Funding for the FLOW Trial is being provided by a grant from the Brain Canada Foundation in partnership with CPSR.
More information may be found at: https://www.canadianstroke.ca/en/research/flow-trial
Your Impact
Participants in clinical studies can play a more active role in their healthcare, gain access to potential new treatments, and help others by contributing to research.
Eligibility Criteria
All genders
At least 25 years old
25 years of age or older
Experienced a stroke between 2 to 12 months ago
Have significant leg weakness in at least one leg
Study Tasks
Attend 3 assessment sessions
Take study medication for 19-21 weeks
Participate in 1-hour physical exercise sessions 3 times a week for 12 weeks
Ethics
FLOW study has been approved by the University Health Network Research Ethics Board. CAPCR ID 18-6002
Keywords
Activity and Time
Investigational Medicine, Health and Wellness
Intervention
Weekdays
1 hour(s) per session
36 session(s)
The FLOW trial will evaluate the effect of combining an antidepressant (e.g. fluoxetine, known more commonly as Prozac) with exercise rehabilitation across multiple Canadian sites in 176 stroke patients. Fluoxetine has been shown in animal models to keep open the period of recovery post-stroke. The trial rationale is that motor function will be significantly improved by pairing fluoxetine with a task-based exercise program. Funding for the FLOW Trial is being provided by a grant from the Brain Canada Foundation in partnership with CPSR. If you decide to participate then you will be "randomized" into one of two groups. Randomization means that you will have an equal (50/50) chance of being placed in either group. Neither you, nor the study staff can choose what group you will be in. This is also a double-blind study, which means that neither you, nor the study staff, will know which group you are in. 88 patients will be enrolled in each group of the study. Both groups will receive a 12-week exercise program (in addition to standard of care rehabilitation), but only one group (the intervention group) will receive the active drug fluoxetine. The other group will receive a placebo. A placebo is a pill that looks the same as the fluoxetine pill but actually contains no active ingredients. It is given in this study to reduce the chances of believing that one’s recovery is improving because one is receiving a new drug. We don’t know if fluoxetine is better than standard care, so we are doing this study to try and find that out.
Compensation
Do this one out of kindness
Reimbursement
A stipend towards parking and/or public transit travel expenses will be provided.
Study Address
347 Rumsey Rd Toronto, Ontario, Canada, M4G 2V6