Please refer to the individual trials to learn more about recruitment. Some trials are actively recruiting participants, while others have closed enrolment.
Each trial includes details of inclusion and exclusion criteria – namely, who can participate in each trial based on the time since stroke, mobility, and other factors.
To learn more about becoming a trial participant, please contact info@canadianstroke.ca
CanStroke Recovery Trials platform welcomes both academic and industry trials. New trials are evaluated by the management team and Steering Committee based on relevance, potential impact, and capacity.
Dr. Sean Dukelow, above, is the study leader
Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke: CAMAROS
Description:
After stroke, the combination of progressive skills practice in an adequate dose, exercise for fitness augments motor and cognitive outcomes. However, sensorimotor and cognitive improvements often plateau after 12 weeks. There is an urgent need to find novel methods to drive recovery and lessen limb paralysis. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, may augment skills learning during rehabilitation training especially during the first three months after onset, by acting on unique molecular components for novel learning.
The CAMAROS trial is a randomized, placebo-controlled, blinded phase II trial evaluating the efficacy of coupling Maraviroc (Celsentri) with exercise rehabilitation across multiple Canadian sites in 120 stroke participants. Participants will begin their participation within 6 weeks of stroke onset. Both groups will receive an exercise program in addition to standard of care rehabilitation, but only one group (the intervention group) will receive the active drug Maraviroc.
Participants will be evaluated using physical assessments, cognitive assessments, and using wrist and ankle activity sensors at baseline, after 4 weeks of taking the drug/placebo, after 8 weeks of taking the drug/placebo, and at 6-months post-stroke. While enrolled in the study, participants will be required to take part in an 8 week, daily exercise program. Participants will also perform a short motor learning assessment at each formal assessment and again within 24 hours of each formal assessment (initial test and 24-hour retention test).
Sites involved:
- Vancouver, BC
- Kelowna, BC
- Calgary, AB
- London, ON
- Toronto, ON
- Kingston, ON
- Windsor, ON
- Quebec City, QC
- Halifax, NS
- Charlottetown, PEI
Principal Investigator:
Dr. Sean Dukelow, MD, PhD, University of Calgary/Hotchkiss Brain Institute
Other Investigators:
Vancouver, BC:
Drs Janice Eng, Courtney Pollock, Jennifer Yao
Kelowna, BC:
Drs Brodie Sakakibara, Aleksander Tkach
Calgary, AB:
Drs Sean Dukelow, Gentson Leung
London, ON:
Dr. Robert Teasell
Toronto, ON:
Drs Mark Bayley, Bradley MacIntosh, Sandra Black
Kingston, ON:
Drs Stephen Scott, Benjamin Ritsma
Windsor, ON:
Drs Jennifer Voth, Nathania Liem
Quebec City, QC
Dr. Catherine Mercier
Halifax, NS:
Drs Marilyn Mackay-Lyons, Anita Mountain
Charlottetown, PEI:
Drs Trish Helms-Neima, Nathanial Heinrichs
Target population:
Individuals within 5 days and 6 weeks of stroke who are experiencing hemiparesis requiring inpatient rehabilitation.
Recruitment:
The trial is currently recruiting participants. Target recruitment n = 120.
Eligibility:
Inclusion Criteria
- Primary ischemic anterior circulation stroke
- age ≥18 years
- at least 5 days after stroke but within 6 weeks of stroke on the date of medication (maraviroc or placebo) start
- hemiparesis requiring inpatient rehabilitation
- at least one of the following:
- some shoulder abduction, with gravity eliminated and visible extension in two or more digits
OR - visible hip flexion or extension
- some shoulder abduction, with gravity eliminated and visible extension in two or more digits
- assistance available for daily rehabilitation training practice and for transportation when needed
- adequate language skills to understand the Informed Consent and retain information during daily therapies
Exclusion Criteria
- pre-stroke modified Rankin score ≥ 2
- limited resources or illness that will not enable a return to living outside of a facility
- history of dementia
- history of hepatitis or elevated hepatic transaminases or bilirubin
- history of renal insufficiency or creatinine clearance (eGFR) < 60mL / min / 1.73m2
- cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
- existing pre-stroke serious disabling disease (e.g., Parkinson’s disease, severe traumatic brain injury, amputation)
- seizure related to stroke
- acute or chronic epilepsy
- currently taking any of the following anticonvulsant medications:
- Carbamazepine, Phenobarbital, or Phenytoin
- pregnant, breastfeeding, or positive test for pregnancy at baseline
- women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
- known HIV positivity
- currently taking any of the following antifungal and/or antibacterial medications:
- Ketoconazole, Itraconazole, Voriconazole, Rifampin, Clarithromycin, or Rifabutin + Protease Inhibitor
- currently taking St. John’s Wort
Subgroup Stratification Criteria
For Upper Extremity Group:
Minimum Ability: Medical Research Council (MRC) grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least one digit
Maximum Ability: Upper Extremity Fugl-Meyer Assessment Score >56
For Lower Extremity Group:
Minimum Ability: requiring a 2-person assist
Maximum Ability: walking speed <0.8m/s
Dr. Mark Bayley, above, is the study leader.
Exploring Methods to improve Participation Of Women in clinical trials to Help Enhance stroke Recovery research: EMPOW-HER
Description:
Sex differences exist in the burden of stroke and treatment efficacy, therefore equal representation in research studies is of paramount importance. However, women are under-represented in stroke research trials reducing the generalizability of research outcomes.
Therefore, we are conducting two cross-sectional questionnaire-based studies and one focus group to determine sex and gender-related factors associated with willingness to participate in stroke research studies. A retrospective review of CanStroke Recovery Trials data is also underway, to determine whether the sex distribution as well as other demographic and clinical characteristics of participants differed from that of the general diseased population.
Sites Involved:
A survey of the CanStroke research team will be sent to all current CanStroke personnel to explore their perceptions of barriers and facilitators to recruitment of women and men in clinical trials.
Respondents for the survey of people post-stroke will be recruited from 9 sources across Canada. These include in-patient and out-patient stroke rehabilitation programs, cardiovascular rehabilitation, and March of Dimes.
We will also be contacting the CanStroke Trials Recovery Platform researchers to invite them to disseminate research flyers to the patients of their studies.
Principal Investigator:
Dr. Mark Bayley, MD
Other Investigators:
Dr. Susan Marzolini
Dr. Shannon MacDonald
Dr. Urvashy Gopaul
Dr. Amy Yu
Juliana Nunes da Silva
And others from the CanStroke research team.
Target population:
The CanStroke Recovery Trials research team.
Men and women post-stroke.
Recruitment:
Recruitment is underway for the cross-sectional questionnaire of people post-stroke (target of 400 respondents).
Study eligibility:
Men and women (at least 18 years of age) having had at least one stroke (any type).
Ability to read in English.
Internet-delivered cognitive behavioural therapy for persons with stroke: ICBT
Description:
In Canada, stroke is a leading cause of adult disability. Along with the physical concerns, approximately 30% of people often experience symptoms of depression, but only 2- 3% access support. Unhelpful thoughts of never being able to go back to their life before their stroke and fear of recurring stroke can result in feelings of loss and hopelessness. If these thoughts go untreated over a long period of time, they can potentially lead to decreased quality of life and greater disability. Many of these individuals may benefit from access to mental health services, eg. cognitive behaviour therapy (CBT), that target maladaptive thoughts and behaviours. CBT is an evidenced based treatment strategy that helps patients recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, after stroke people often go untreated for various reasons, such as access to specialized care, costs, rural and remote location, lack of time, or concerns about stigma related to seeking care. One way to overcome these barriers is to provide these services over the internet. Internet delivered CBT (ICBT) has the potential for reaching a much wider group of people that may have unequal access to services.
Sites Involved:
- Canada-wide (Virtual)
Principal Investigator:
Swati Mehta, PhD Lawson Health Research Institute
Robert Teassel, MD St. Joseph’s Health Care London
Eligibility:
- Participants who have sustained a stroke and would like to learn strategies to improve their emotional well-being.
- The program is tailored to those with stroke that may have mobility and cognitive impairments.
Participant requirements:
Participants will be enrolled in an online 10-week program with potential guidance from a trained mental health clinician each week over the phone or through videoconferencing.
To learn more: swati.mehta@sjhc.london.on.ca
Dr. Sean Dukelow, pictured here, is the study leader.
Robot-Enhanced Stroke Therapy Optimizes REhabilitation: RESTORE
Description:
Robotics in upper limb stroke rehabilitation first garnered attention in late 1990’s. Robots were a way to 1) perform passive range of motion and reduce hypertonia (resistance to passive movement), 2) aid patients in performing movements that would not otherwise be possible because of weakness and 3) increase strength by providing resistance to movements. The first observational study focused on chronic stroke and showed that working with a simple robotic device, the MIT-Manus, could improve motor function. Many observational studies using robotics for motor rehabilitation followed. As the number and complexity of robots increased, so did study designs.
Case-control and small single centre randomized controlled trials evaluated robotic therapy versus standard rehabilitation care or sham therapy. In most studies, robotic rehabilitation proved superior to the control conditions.
The purpose of this study is to investigate two aspects of robotic therapy after stroke. One goal is to determine if early robotic rehabilitation of the upper limb (beginning 5-9 days post-stroke) is more effective than later robotic rehabilitation (beginning 21-25 days post-stroke). The other goal is to determine if higher intensity robotic rehabilitation (2 hours/day) is more effective than lower intensity robotic rehabilitation (1 hour/day).
Sites Involved:
Calgary, AB
Kingston, ON
Principal Investigator
Dr. Sean Dukelow, MD, PhD, University of Calgary, Hotchkiss Brain Institute
Other Investigators:
Calgary, AB
Dr. Sean Dukelow
Kingston, ON
Drs Stephen Scott, Benjamin Ritsma
Target Population:
Individuals experiencing a recent first stroke who are experiencing an upper extremity impairment.
Recruitment:
The trial is currently recruiting participants.
Target recruitment n = 132 stroke participant, n=24 control participants.
Study Eligibility:
Inclusion Criteria – Stroke:
- Recent first stroke (ischemic or hemorrhagic)
- Upper extremity Fugl-Meyer score 15-45
- Modified Ashworth score of shoulder/elbow less than or equal to 2
- Able to follow task instructions
- Visual acuity better than 20/50 in both eyes
- Able to give consent
- Able to commit to follow-up
Inclusion Criteria – Control:
- Aged 18 or older
- Visual acuity better than 20/50 in both eyes
- Able to give consent
- Able to complete intervention
Exclusion Criteria:
- Prior stroke or significant neurologic problem (e.g. Multiple Sclerosis)
- Pre-existing musculoskeletal injury that will interfere with active therapy
- Pre-Stroke Modified Rankin Score > 2
- Clinical evidence of Unilateral Spatial Neglect on the Behavioural Inattention Test (BIT)
- Enrollment in a concurrent clinical intervention trial
- Major co-morbid or concurrent illness such that improvement is unlikely or completion of the protocol as specified is unlikely
Drs Brodie Sakakibara and Ada Tang, pictured here, are the study leaders.
TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke: TRAIL
TRAIL Randomized Controlled Trial (TRAIL-RCT)
Description:
The multi-site RCT aims to compare functional mobility between stroke survivors in TRAIL, a 4-week progressive intensity and self-management support telerehabilitation program, and those in the attention-controlled stroke education program (EDUCATION). The trial also compares lower extremity muscle strength, motor impairment, functional balance, balance self-efficacy, and costs and health-related quality of life between TRAIL and EDUCATION participants.
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 under-serviced areas.
Sites involved:
- Vancouver
- Kelowna
- Winnipeg
- Halifax
- Toronto
- London
Principal Investigators:
Dr. Ada Tang, McMaster University
Dr. Brodie Sakakibara, University of British Columbia, Okanagan
Other investigators:
- Nova Scotia Health Authority (Halifax), site investigator Dr. Marilyn Mackay-Lyons,
- University Health Network (Toronto), site investigator Dr. Mark Bayley,
- Parkwood Institute (London), Dr. Robert Teasell,
- Riverview Health Centre (Winnipeg), Dr. Ruth Barclay & Dr. Sepideh Pooyania,
- GF Strong Rehabilitation Centre (Vancouver), Dr. Courtney Pollock.
- McMaster University (Hamilton), Elise Wiley, PhD candidate
- Patient Partner, Jennifer Monaghan
Target population for the trial:
Individuals within 12 months of stroke who are experiencing lower extremity impairment.
Recruitment:
The trial is currently recruiting participants
Target recruitment n=96 (n=48 females, 48 males)
Study eligibility:
Inclusion Criteria:
- ≥19 years of age
- ≤12 months post-stroke with lower extremity hemiparesis
- Walk ≥10 meters with or without a gait aid and without physical assistance of another person
- Tolerate 50 minutes of activity (including rest breaks)
Exclusion Criteria:
- Currently participating in formal in- or out-patient stroke rehabilitation focusing on lower extremity training
- Living in long-term care
- Severe vision or hearing loss
- Significant musculoskeletal or other neurological conditions
- Not medically stable
- Comorbidities (e.g. limb amputation), pain or other symptoms that significantly impact lower extremity
To learn more: info@canadianstroke.ca
Telerehabilitation with Aims to Improve Lower Extremity Recovery – Proof-of-Concept (TRAIL-PROOF)
The TRAIL-RCT was preceded by a proof-of-concept study, TRAIL-PROOF.
Description:
TRAIL-Proof was a feasibility study aiming to examine the feasibility of a 4-week lower extremity telerehabilitation program to improve lower extremity recovery among community-living stroke survivors across Canada. Thirty-two patients have been enrolled in the study at 5 Canadian sites.
Participants received a telerehabilitation program comprised of evidence-based exercises and self-management delivered by physiotherapist trained in telerehabilitation over videoconferencing. The program consisted of two 60-minute telerehabilitation sessions per week over the course of 4 weeks. Participants were also asked to complete at least one additional independent self-managed exercise session each week. Study participants were evaluated before the start of the telerehabilitation program and immediately after the telerehabilitation program.
Sites involved:
University of British Columbia & GF Strong Centre, Vancouver, British Columbia
Riverview Health Centre, Winnipeg, Manitoba
Dalhousie University, Halifax, Nova Scotia
Parkwood Institute, London, Ontario
Toronto Rehabilitation Institute – University Health Network, Toronto, Ontario
Principal Investigators:
Brodie Sakakibara, PhD
Ada Tang PT PhD
Other Investigators:
Mark Bayley, MD. University Health Network, Toronto
Courtney Pollock, PhD. University of British Columbia & Rehabilitation Research Program
Janice Eng, PhD. University of British Columbia & Rehabilitation Research Program
Sepideh Pooyania, MD. Riverview Health Centre
Ruth Barclay, PhD. Riverview Health Centre
Marilyn Mackay-Lyons, PhD. Dalhousie University
Robert Teasell, MD. Parkwood Institute
Sarah Park, MSc, University of British Columbia & Rehabilitation Research Program
TRAIL Publications
May 24, 2024 Associations between balance self-efficacy and virtual balance performance
Examining the association between balance self-efficacy and virtual balance performance in individuals with stroke: a cross-sectional study
Authors: Eric Huynh, Elise Wiley, Sarah Park, Brodie M Sakakibara, Ada Tang
Published in Top Stroke Rehabil. 2024 May 24:1-9. doi: 10.1080/10749357.2024.2356407. Online ahead of print.
Link to paper https://www.tandfonline.com/doi/full/10.1080/10749357.2024.2356407
March 1, 2024 Results from TRAIL Proof of Concept Study
Investigating the Telerehabilitation With Aims to Improve Lower Extremity Recovery Poststroke Program: A Feasibility Study
Authors: Sarah Park, Ada Tang, Ruth Barclay, Mark Bayley, Janice J Eng, Marilyn Mackay-Lyons, Courtney Pollock, Sepideh Pooyania, Robert Teasell, Jennifer Yao, Brodie M Sakakibara
Published in Phys Ther. 2024 Mar 1;104(3):pzad165. doi: 10.1093/ptj/pzad165.
Link to paper: https://pubmed.ncbi.nlm.nih.gov/38051660/
February 15, 2024 Qualitative study of participant experiences of TRAIL
Exploring the experiences of an exercise-based telerehabilitation program among Canadian community-dwelling adults with stroke
Authors: Elise Wiley, Brodie Sakakibara, Sarah Park, Ruth Barclay, Mark Bayley, Janice J Eng, Anne Harris, Elizabeth Inness, Marilyn MacKay-Lyons, Joy MacDermid, Courtney Pollock, Sepideh Pooyania, Robert Teasell, Jennifer Yao, Ada Tang
Published in Disabil Rehabil. 2024 Feb 15:1-11. doi: 10.1080/09638288.2024.2316772. Online ahead of print.
Link to paper https://www.tandfonline.com/doi/full/10.1080/09638288.2024.2316772
July 19, 2023 Protocol for TRAIL Randomized Controlled Trial
TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial
Authors: Brodie M Sakakibara, Elise Wiley, Ruth Barclay, Mark Bayley, Jennifer C Davis, Janice J Eng, Anne Harris, Elizabeth L Inness, Marilyn MacKay-Lyons, Jennifer Monaghan, Courtney Pollock, Sepideh Pooyania, Amy Schneeberg, Robert Teasell, Jennifer Yao, Ada Tang
Published in BMJ Open. 2023 Jul 19;13(7):e076723. Doi: 10.1136/bmjopen-2023-076723.
Link to paper: https://bmjopen.bmj.com/content/13/7/e076723.long
TRAIL In the News
28 March 2024 UBC Okanagan News, Virtual rehabilitation provides benefits for stroke recovery https://news.ok.ubc.ca/2024/03/28/virtual-rehabilitation-provides-benefits-for-stroke-recovery/
July 10, 2022 Vancouver Coastal Health Research Institute article, Making lower body rehabilitation more accessible to stroke patients https://www.vchri.ca/stories/2022/07/10/making-lower-body-rehabilitation-more-accessible-stroke-patients
19 January 2022 Interview with UK-based NR Times, TRAIL study brings new remote rehab potential to stroke survivors https://nrtimes.co.uk/trail-study-brings-new-remote-rehab-potential-to-stroke-survivors/
Dr. Janice Eng
Virtual Physical Activity Seated Exercise Study: V-PASE
Description:
The Virtual Physical Activity Seated Exercise (V-PASE) study is a 10-week online exercise study in those living with a stroke and mobility impairment. The study has the potential to improve an individual’s balance, mobility, muscle strength, quality of life, and heart health (sugar and cholesterol levels).
The study is conducted in multiple provinces across Canada with all sessions being completed online (e.g., Zoom) in the comfort of your own home. Intensive seated exercise sessions will be delivered by a trained instructor or physical therapist and will be 60 minutes in duration and take place 3 times per week.
Who can join this study?
- Adults who have been living with stroke more than 6 months
- Live in BC, Saskatchewan, Manitoba, Ontario, or Nova Scotia
- Have ongoing walking and standing issues due to their stroke
- Use a walking device such as a cane or walker in large indoor spaces (e.g., shopping mall) or outdoor spaces, and
- Able to stand up from a chair.
Principal Investigator:
Dr. Janice Eng, University of British Columbia
Other investigators:
British Columbia – Dr. Paul Mackie | Dr. Jennifer Yao | Dr. Ben Mortenson | Sally-Anne Stelling | Dr. Courtney Pollock | Dr. Maureen Ashe | Dr. Brodie Sakakibara
Saskatchewan – Dr. Sarah Donkers
Manitoba – Dr. Ruth Barclay | Dr. Sepideh Pooyania
Ontario – Dr. Sue Peters | Dr. Mark Bayley
Nova Scotia – Dr. Adria Quigley
Target population for the trial:
Adults living with a stroke for more than 6 months and have a mobility impairment (walking difficulties that require a walking device in outdoor spaces or large indoor areas).
Access to a local blood facility for sugar and cholesterol lab work is needed. We can work with local health authorities to schedule blood work.
Recruitment:
The trial is currently recruiting patients in all Provinces listed above.
To learn more: info@canadianstroke.ca
Description:
This study examines the feasibility and effect of a program that combines exercise and feedback from a wearable device on upper limb movement practice and function in individuals with stroke.
Participants were randomized into either the Immediate Treatment Group or the Delayed Treatment group. Both groups completed the same intervention program. The Immediate treatment group started the program right away while the Delayed Treatment group started the program after a 3-week delay.
The intervention program is 3 weeks in duration and consists of participants completing at least two hours of exercises (adapted from the Home-GRASP program) daily and wearing an activity monitor on their affected wrist during waking hours for the duration of the intervention. Participants were asked to meet daily movement count goals based on information from the monitor and had 6 virtual sessions with a therapist.
Sites involved:
- GF Strong Rehab Centre, Vancouver, British Columbia, Canada
- University of Calgary, Calgary, Alberta, Canada
- Riverview Health Centre, Winnipeg, Manitoba, Canada
- Parkwood Institute, London, Ontario, Canada,
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Toronto Rehabilitation Institute – University Health Network, Toronto, Ontario, Canada
- Dalhousie University, Halifax, Nova Scotia, Canada
Principal Investigator:
Dr. Janice Eng, University of British Columbia
Other investigators:
Dr. Sean Dukelow (Calgary, AB)
Dr. Ruth Barclay (Winnipeg, MB)
Dr. Bob Teasell (London, ON)
Dr. Bradley MacIntosh (Toronto, ON)
Dr. Mark Bayley (Toronto, ON)
Dr. Marilyn MacKay-Lyons (Halifax, NS)
Target population:
Adults living with a stroke less than one year and have a mobility impairment on stroke affected upper limb
Recruitment:
Data collection has been completed. 62 participants were enrolled in the study.
Study eligibility:
- 19 years or older
- Less than 1 year since the stroke occurred
- Living in the community
- Have unilateral upper limb impairment
- Have some ability to move their arm and hand (> 30° shoulder flexion or abduction and Fugl Meyer finger extension score > 0)
- Are using their affected upper limb in a different way than prior to their stroke (REACH score < 4)
- Completed formal physical and occupational therapy rehabilitation for the upper limb
- Have access to a tablet, computer, laptop or phone with internet and email access.
The trial protocol is published at the following site
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06047-9
FLuoxetine to Open the critical time period Window to improve motor recovery after stroke: FLOW
Description:
FLOW Trial is a randomized, placebo-controlled, blinded phase II trial evaluating the efficacy of coupling antidepressant therapy (e.g., selective serotonin reuptake inhibitor – fluoxetine) with exercise rehabilitation in expanding the window of post-stroke recovery and improving functional outcomes. 52 patients have been enrolled in the study at 8 Canadian sites.
Participants were randomized into the intervention and the control group. The intervention group received a low dose of active drug fluoxetine, while the control group received placebo. Both groups received a 12-week, 3 times per week exercise program in addition to standard of care rehabilitation. Study participants were evaluated at baseline, post-exercise program and 6-months post-exercise program.
Sites Involved:
- University of Calgary, Calgary, Alberta,
- University of British Columbia & GF Strong Centre, Vancouver, British Columbia
- Riverview Health Centre, Winnipeg, Manitoba,
- Memorial University of Newfoundland, St. John’s, Newfoundland and Labrador
- Dalhousie University, Halifax, Nova Scotia,
- Parkwood Institute, London, Ontario
- Sunnybrook Health Sciences Centre, Toronto, Ontario
- Toronto Rehabilitation Institute – University Health Network, Toronto, Ontario
Principal Investigators:
Dr. Mark Bayley and Dr. Janice Eng
Other Investigators:
Dr. Mark Bayley, MD. University Health Network, Toronto
Dr. Courtney Pollock, PhD. University of British Columbia & GF Strong Rehab Centre
Dr. Bradley MacIntosh, PhD, Sunnybrook Health Sciences Centre
Dr. Sean Dukelow, MD, PhD, University of Calgary/Hotchkiss Brain Institute
Dr. Sepideh Pooyania, MD. Riverview Health Centre
Dr. Michelle Ploughman, PhD. Memorial University of Newfoundland
Dr. Marilyn Mackay-Lyons, PhD. Dalhousie University
Dr. Robert Teasell, MD. Parkwood Institute
Dr. Marc Roig, McGill, University, Quebec
Target Population:
Individuals within 12 months of stroke who are experiencing lower extremity impairment.
Recruitment:
The trial is not recruiting patients. Recruitment and data collection have been completed and researchers have begun analysis of the results.
Eligibility:
Inclusion Criteria:
- 25 years of age or older
- Between 2 to 12 months post-stroke
- Experiencing significant weakness in one or both legs as the result of stroke
- Not currently taking SSRIs or MOIs
Exclusion Criteria:
Pregnancy
Pre-existing conditions causing severe impairment of mobility
Taking medications for depression
Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
Uncontrolled high blood pressure
Requires more than a one person assist for transfer
Planned surgery that would affect participation in the trial
Participating in another formal lower limbs exercise program more than one day per week
History of seizures
Dr. Mark Bayley, pictured above, is one of the study leaders.
Modafinil and Exercise for Post Stroke Fatigue: MODEX
Description:
A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. We do not fully understand all the reasons for fatigue after stroke or how to best treat it. We think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength.
Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment so our study has two main aims:
- Test which type of exercise is best.
- Test if Modafinil is better than a sugar pill.
As another aim, we will also look at if combining Modafinil with exercise has any benefits.
We will assess the results to identify the best treatment for post stroke fatigue. We hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke.
Sites Involved:
- Toronto (UHN and Sunnybrook)
- London, ON
- Vancouver
- Calgary
- Winnipeg
- Halifax
- St. John’s
Principal Investigators:
Dr. Mark Bayley, MD
Dr. Janice Eng, PhD
Other Investigators:
Dr. Mark Bayley, Toronto Rehabilitation Institute – University Health Network
Drs. Bradley MacIntosh and Sandra Black, Sunnybrook Health Sciences Centre
Dr. Sean Dukelow, University of Calgary
Drs. Jennifer Yao, Janice Eng, and Courtney Pollock, University of British Columbia & GF Strong Rehab Centre
Drs. Michelle Ploughman and Jason McCarthy, Memorial University of Newfoundland
Drs. Marilyn Mackay-Lyons and Anita Mountain, Dalhousie University
Dr. Robert Teasell, Parkwood Institute
Drs. Sepideh Pooyania and Ruth Barclay, Riverview Health Centre
Target Population:
Individuals with fatigue > 3 months post stroke.
Recruitment:
Not recruiting yet.
Target number: up to n=300.
Eligibility:
Inclusion Criteria:
- >18 years of age
- >3 months post stroke onset (i.e. intracerebral hemorrhage or ischemic stroke diagnosed by a physician)
- evidence of stroke on computed tomography or magnetic resonance imaging
- disabling post stroke fatigue as measured by Multidimensional Fatigue Inventory score >60
- Modified Rankin disability score <4
- mobile enough to participate in exercise (i.e. able to walk with one person assistance or less)
Exclusion Criteria:
- Contraindications to Modafinil
- On stimulant medications already
- subarachnoid hemorrhage
- impaired comprehension or language impairment that prevents following visual or pictograph adapted instructions and providing informed consent
- severe motor impairment and inability to participate in the exercise
- unable to participate in exercise due to musculoskeletal complaints, unstable heart failure, or renal disease
- untreated hypothyroidism or anemia
- cancer likely to result in death in less than 6 months
- severe depression requiring therapy as indicated by suicidal ideation and/or DASS depression sub-score > 20
- currently enrolled in a structured exercise program
- untreated severe sleep apnea with an Apnea/Hypopnea index >30
More information coming soon!
