Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada

Launched by MCMASTER UNIVERSITY · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving stroke rehabilitation research in Canada. Stroke is a serious health issue, affecting over 400,000 Canadians, and it’s crucial to understand how different treatments can help people recover. However, many groups, like women and individuals with language difficulties (known as aphasia), are often left out of research studies. This trial aims to find better ways to encourage these underrepresented groups to participate, ensuring that the findings reflect the experiences of all stroke survivors.

To be eligible for the trial, participants must be at least 18 years old and have had a specific type of stroke that affects their ability to move on one side of their body. They should be within 5 to 8 weeks of their stroke and need assistance for rehabilitation. Participants will receive either a medication called Maraviroc or a placebo (a substance with no active effect) to help assess its impact on recovery. It’s important for potential participants to know that this study is not yet recruiting, but it aims to create a more inclusive environment for stroke research in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary ischemic anterior circulation stroke
• • 2. Age ≥18 years
• • 3. ≥5 days but \<8 weeks after stroke on the date of medication (Maraviroc or placebo) start
• • 4. Hemiparesis requiring inpatient rehabilitation
• • 5. Assistance available for daily rehabilitation training practice and for transportation when needed
• • 6. Adequate language skills to understand Informed Consent and retain information during daily therapies
• • 7. 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
• Exclusion Criteria:
• • 1. Pre-stroke modified Rankin score ≥2
• • 2. Limited resources or illness that will not enable a return to living outside of a facility
• • 3. History of dementia
• • 4. History of hepatitis or elevated hepatic transaminases or bilirubin
• • 5. History of renal insufficiency or creatinine clearance (eGFR) \<60mL / min / 1.73m2
• • 6. Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
• • 7. Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
• • 8. Seizure related to stroke
• • 9. Acute or chronic epilepsy
• • 10. Currently taking any of the following anticonvulsant medications: Carbamazepine, Phenobarbital, Phenytoin
• • 11. Pregnant, breastfeeding, or positive test for pregnancy at baseline
• • 12. Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
• • 13. Known HIV positivity
• • 14. Currently taking any of the following antifungal and/or antibacterial medications: Ketoconazole, Itraconazole, Voriconazole, Rifampin, Clarithromycin, Rifabutin + Protease Inhibitor
• • 15. Currently taking St. John's Wort