Improving recruitment for stroke rehabilitation trials in Canada
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
This study is trying out a new way to recruit women and people with aphasia for stroke rehabilitation trials in Canada by using videos and leaflets to see if it helps them join these important studies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Trial ID | NCT06576089 on ClinicalTrials.gov |
What this trial studies
This pilot project aims to enhance recruitment for stroke rehabilitation trials by developing a women-centered and aphasia-friendly approach. It will assess the feasibility of using a video and leaflet to support traditional recruitment methods, focusing on underrepresented groups such as women and individuals with aphasia. The study will also explore barriers and facilitators to participation in stroke recovery trials and provide preliminary estimates of the effectiveness of the new recruitment strategy compared to standard methods. The research will be conducted across multiple sites in Canada.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a primary ischemic anterior circulation stroke and are within 5 to 8 weeks post-stroke.
Not a fit: Patients with a pre-stroke modified Rankin score of 2 or higher, or those with significant comorbidities that limit their ability to participate in rehabilitation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more equitable representation in stroke rehabilitation research, ultimately improving treatment outcomes for diverse patient populations.
How similar studies have performed: While there have been studies focusing on recruitment strategies in clinical trials, this specific approach targeting women and individuals with aphasia in stroke rehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta and 4 other locations
- University of Calgary & Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- University of British Columbia & GF Strong Rehabilitation Centre — Vancouver, British Columbia, Canada (Recruiting)
- Dalhousie University — Halifax, Nova Scotia, Canada (Recruiting)
- Parkwood Institute — London, Ontario, Canada (Recruiting)
- Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Ada Tang, PT PhD
- Email: atang@mcmaster.ca
- Phone: 289-426-5768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.