Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT06576089

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)

Traditional recruitment and enrollment processes (TRAD)

Study Details

Brief summary:

Stroke is a major health issue in Canada. Stroke affects over 400,000 Canadians, and this number is expected to nearly double by 2038. Research studies in stroke recovery can help us better understand effective rehabilitation treatments and help reduce the burden of stroke. Some groups of people however are commonly not included in stroke studies. For example, it is more common for men to take part in research than women, and people with aphasia (a language impairment commonly seen after stroke) are often excluded from studies. Also, deciding whether to even take part in a research study can be difficult and overwhelming, especially in the early days after stroke, leaving many people to decline to participate. Research has shown that women experience different barriers to participating in stroke research than men. This means that research findings, and the decisions made during stroke care based on these findings, may not reflect the true stroke population. Better ways to help support groups like women and people with aphasia to participate in stroke research are needed, so that study findings will better represent people living with stroke.

Conditions

Stroke

Study ID

NCT06576089

Start date

Jun 16, 2025

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Traditional recruitment and enrollment processes (TRAD)

Traditional participant information letter and consent form only (TRAD)

experimental: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)

Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER)

Interventions

Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)

Participants randomized into ORDER will be approached by the Site Coordinator for interest in the host trial. The Coordinator will introduce the trial and share a brief, women-centred, aphasia-friendly, close-captioned video that further describes the trial procedures and an accompanying leaflet.

ORDER recruitment materials will be saved to a mobile tablet. The Coordinator will watch the video together with the potential participant, engage in discussion about the host trial and answer any questions they may have. The Coordinator will offer to leave the tablet with the potential participant, along with printed copies of the leaflet and participant information letter. The Coordinator will encourage them to share these materials with their family members, friends or member of their healthcare team who may assist with decision making. The Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.

Traditional recruitment and enrollment processes (TRAD)

Participants randomized into the traditional recruitment process (TRAD) will be approached by the Site Coordinator for interest in the CAMAROS trial and presented with the standard participant information letter and full informed consent form. The information letter and consent form will be left with the potential participant to view again; the Coordinator will encourage them to share these materials with their family members or friends who may assist with decision making. The Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.

Primary outcome measure

  • Feasibility [ Time Frame: From date identified as eligible for the host trial to date of decision (consent or decline) ]
  • Barriers and facilitators [ Time Frame: From date of decision (consent or decline) for host trial to date of survey or interview ]
  • Preliminary estimates of effect [ Time Frame: From date identified as eligible for the host trial to date of decision (consent or decline) ]

Central Contacts and Locations

Central contacts

Ada Tang, PT PhD

289-426-5768atang@mcmaster.ca

Hanna Fang

289-426-0468fangh@mcmaster.ca

Locations

University of Calgary & Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Alex McKinnon

403-944-4050alexandra.mckinnon@ucalgary.ca

Principal Investigator:

Sean Dukelow, MD PhD

University of British Columbia & GF Strong Rehabilitation Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2G9

Contacts

Courtney Pollock

604-827-1631courtney.pollock@ubc.ca

Principal Investigator:

Janice Eng, PhD

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 3J5

Contacts

Melanie Dunlop

902-473-1401Melanie.Dunlop@nshealth.ca

Principal Investigator:

Marilyn MacKay-Lyons, PhD

Parkwood Institute

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Shiela Geniblazo

Shiela.Geniblazo@sjhc.london.on.ca

Principal Investigator:

Robert Teasell, MD

More Information

Sponsor

McMaster University

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • Stroke rehabilitation
  • Clinical trial
  • Informed consent
  • Diversity, Equity, Inclusion
  • Sex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-09-26.