StrokeORDER-PNCT06576089
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada
A study testing Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) and Traditional recruitment and enrollment processes (TRAD) in people with Stroke, run by McMaster University at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) and Traditional recruitment and enrollment processes (TRAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesCanada
- Study dates
- 16 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- ≥5 days but <8 weeks after stroke on the date of medication (Maraviroc or placebo) start
- Hemiparesis requiring inpatient rehabilitation
- Assistance available for daily rehabilitation training practice and for transportation when needed
- Adequate language skills to understand Informed Consent and retain information during daily therapies
- 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
Who cannot join
- 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
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- 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, 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, Rifabutin + Protease Inhibitor
- Currently taking St. John's Wort
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
University of Calgary & Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Alex McKinnon, 403-944-4050, alexandra.mckinnon@ucalgary.ca
Sean Dukelow, MD PhD
- Recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 3J5
Melanie Dunlop, 902-473-1401, Melanie.Dunlop@nshealth.ca
Marilyn MacKay-Lyons, PhD
- Recruiting
Parkwood Institute
London, Ontario, N6C 0A7
Shiela Geniblazo, Shiela.Geniblazo@sjhc.london.on.ca
Robert Teasell, MD
- Not yet recruiting
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2
Olga Yaroslavtseva, 416-597-3422, olga.yaroslavtseva@uhn.ca
Mark Bayley, MD
- Recruiting
University of British Columbia & GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
Courtney Pollock, 604-827-1631, courtney.pollock@ubc.ca
Janice Eng, PhD
About this study
Official title: Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
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.
Read the detailed description
Clinical trials in stroke recovery are essential for establishing effective treatments, yet important groups, such as women and people with aphasia, have been consistently under-represented in stroke trials. This limits the generalizability of trial findings and impacts clinical care. Relevant to stroke is the critical time window for neuroplastic change that makes timely enrolment into stroke recovery trials of particular importance. There is a need to develop strategies to efficiently and effectively promote participation into stroke recovery trials.
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada (ORDER) is a pilot "study within a trial" to look at a women-centred, aphasia-friendly recruitment method for a research trial examining whether a medication (Maraviroc), when combined with rehabilitation, can help with stroke recovery ("host trial").
The objectives of this pilot study are to:
- Examine the feasibility of a women-centred, aphasia-friendly video and leaflet (ORDER) to supplement traditional detailed participant information letters, support recruitment, and drive enrollment in a stroke recovery randomized trial;
- Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly;
- Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces. The host trial is comparing Maraviroc vs. placebo, combined with 8 weeks of rehabilitation, to improve motor and sensory function.
Potential participants will be identified and approached 5 days to 8 weeks after stroke and randomized to: 1) Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER), or 2) Traditional participant information letter and consent form only (TRAD). For the ORDER arm, the video and leaflet will be saved to a tablet and reviewed together with the Coordinator and potential participant. The Coordinator will engage in discussion about the host trial (prompting questions will be provided), and will offer to leave the tablet with the person, along with printed copies of the leaflet and participant information letter. They will be encouraged to share these materials with their family members or friends who may assist with decision making. For TRAD, the Coordinator will review the information letter and consent form, offer to leave these with the person to view again, and encourage them to share these materials with their family members or friends who may assist with decision making. For both arms, the Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.
Objective 1 Feasibility will be determined as enrollment (# consented/approached, # women consented/total # consented) and efficiency (# days to decision, # interactions between Site Coordinator and potential participants), with a priori criteria for success for each indicator.
For Objective 2 (Barriers and facilitators), individuals will be invited to complete a survey or participate in key-informant, semi-structured interviews (15 enrolled, 15 declined, 10 Site Coordinators) to share their perceptions of the enrollment and consent process, reason(s) for declining to participate, and recruitment reach (# and characteristics of individuals enrolled through ORDER and TRAD). Purposive sampling will be used to obtain diversity across sex (males, females), gender (men, women, transgender, non-binary), and racial background and will train peer researchers with lived experience to conduct the interviews. The interview guide will be co-developed with our patient partners and the research team. Deductive content analysis of interview transcripts will be conducted and mapped to the Theoretical Domains Framework.
For Objective 3 (Preliminary estimates of effect), enrollment and efficiency will be compared between ORDER and TRAD, and Cohen's d and f will be calculated for unadjusted and adjusted analyses to help inform future large-scaled trials.
- Conditions
- Stroke
- Being tested
- Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER), Traditional recruitment and enrollment processes (TRAD)
- Keywords
- Stroke rehabilitation, Clinical trial, Informed consent, Diversity, Equity, Inclusion, Sex
- Medical subject headings
- Stroke, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional recruitment and enrollment processes (TRAD) | Other | Traditional participant information letter and consent form only (TRAD) Receives: Other: Traditional recruitment and enrollment processes (TRAD) |
| Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) | Experimental | Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER) Receives: Other: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
Measured: From date identified as eligible for the host trial to date of decision (consent or decline)
Barriers and facilitators
Short survey and semi-structured interviews to examine the perceptions of the enrollment and consent process of individuals approached to participate in CAMAROS and Site Coordinators. Reason(s) for declining to participate and recruitment reach (# and characteristics of individuals approached for CAMAROS) will also be recorded.
Measured: From date of decision (consent or decline) for host trial to date of survey or interview
Preliminary estimates of effect
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
Measured: From date identified as eligible for the host trial to date of decision (consent or decline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start16 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Tang, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576089
- Sponsor's protocol ID
- ORDER-Pilot
- Acronym
- ORDER-P
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
- ClinicalTrials.gov ID
- NCT06576089
- Acronym / sponsor ID
- ORDER-P / ORDER-Pilot
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Clinical trial, Informed consent, Diversity, Equity, Inclusion, Sex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinical trials in stroke recovery are essential for establishing effective treatments, yet important groups, such as women and people with aphasia, have been consistently under-represented in stroke trials. This limits the generalizability of trial findings and impacts clinical care. Relevant to stroke is the critical time window for neuroplastic change that makes timely enrolment into stroke recovery trials of particular importance. There is a need to develop strategies to efficiently and effectively promote participation into stroke recovery trials.
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada (ORDER) is a pilot "study within a trial" to look at a women-centred, aphasia-friendly recruitment method for a research trial examining whether a medication (Maraviroc), when combined with rehabilitation, can help with stroke recovery ("host trial").
The objectives of this pilot study are to:
- Examine the feasibility of a women-centred, aphasia-friendly video and leaflet (ORDER) to supplement traditional detailed participant information letters, support recruitment, and drive enrollment in a stroke recovery randomized trial;
- Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly;
- Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces. The host trial is comparing Maraviroc vs. placebo, combined with 8 weeks of rehabilitation, to improve motor and sensory function.
Potential participants will be identified and approached 5 days to 8 weeks after stroke and randomized to: 1) Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER), or 2) Traditional participant information letter and consent form only (TRAD). For the ORDER arm, the video and leaflet will be saved to a tablet and reviewed together with the Coordinator and potential participant. The Coordinator will engage in discussion about the host trial (prompting questions will be provided), and will offer to leave the tablet with the person, along with printed copies of the leaflet and participant information letter. They will be encouraged to share these materials with their family members or friends who may assist with decision making. For TRAD, the Coordinator will review the information letter and consent form, offer to leave these with the person to view again, and encourage them to share these materials with their family members or friends who may assist with decision making. For both arms, the Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.
Objective 1 Feasibility will be determined as enrollment (# consented/approached, # women consented/total # consented) and efficiency (# days to decision, # interactions between Site Coordinator and potential participants), with a priori criteria for success for each indicator.
For Objective 2 (Barriers and facilitators), individuals will be invited to complete a survey or participate in key-informant, semi-structured interviews (15 enrolled, 15 declined, 10 Site Coordinators) to share their perceptions of the enrollment and consent process, reason(s) for declining to participate, and recruitment reach (# and characteristics of individuals enrolled through ORDER and TRAD). Purposive sampling will be used to obtain diversity across sex (males, females), gender (men, women, transgender, non-binary), and racial background and will train peer researchers with lived experience to conduct the interviews. The interview guide will be co-developed with our patient partners and the research team. Deductive content analysis of interview transcripts will be conducted and mapped to the Theoretical Domains Framework.
For Objective 3 (Preliminary estimates of effect), enrollment and efficiency will be compared between ORDER and TRAD, and Cohen's d and f will be calculated for unadjusted and adjusted analyses to help inform future large-scaled trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional recruitment and enrollment processes (TRAD) | Other | Other: Traditional recruitment and enrollment processes (TRAD)Traditional participant information letter and consent form only (TRAD) |
| Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) | Experimental | Other: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- ≥5 days but <8 weeks after stroke on the date of medication (Maraviroc or placebo) start
- Hemiparesis requiring inpatient rehabilitation
- Assistance available for daily rehabilitation training practice and for transportation when needed
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) |
| 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. | Other | Traditional recruitment and enrollment processes (TRAD) |
Primary outcome
Feasibility
Time frame: From date identified as eligible for the host trial to date of decision (consent or decline)
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
Barriers and facilitators
Time frame: From date of decision (consent or decline) for host trial to date of survey or interview
Short survey and semi-structured interviews to examine the perceptions of the enrollment and consent process of individuals approached to participate in CAMAROS and Site Coordinators. Reason(s) for declining to participate and recruitment reach (# and characteristics of individuals approached for CAMAROS) will also be recorded.
Preliminary estimates of effect
Time frame: From date identified as eligible for the host trial to date of decision (consent or decline)
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) and Traditional recruitment and enrollment processes (TRAD) in people with Stroke, run by McMaster University at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ada Tang, PT PhD (289-426-5768, atang@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From date identified as eligible for the host trial to date of decision (consent or decline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.