Recruitment Methods for Stroke Rehabilitation

(ORDER-P Trial)

Recruiting at 4 trial locations

Overseen By Hanna Fang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Anticonvulsants, Antifungals, Antibiotics, St. John's Wort

Disqualifiers: Dementia, Cancer, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including specific anticonvulsants, antifungals, antibacterials, and St. John's Wort. If you are on these, you would need to discontinue them to participate.

What data supports the effectiveness of the treatment Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) for stroke rehabilitation?

Research highlights the importance of inclusive and accessible research approaches for people with aphasia (a condition affecting communication after a stroke), emphasizing the need for more accessible consent processes. This suggests that treatments like ORDER, which focus on supportive and inclusive recruitment, could improve participation and outcomes for individuals with aphasia in stroke rehabilitation. ^{1 2 3 4 5}

How does the ORDER treatment for stroke rehabilitation differ from other treatments?

The ORDER treatment is unique because it focuses on a supported, women-centered, and aphasia-friendly recruitment and enrollment process, which is designed to be more inclusive and accessible for people with aphasia (difficulty with language after a stroke). This approach addresses the common issue of exclusion of people with aphasia from stroke trials, aiming to provide more equitable access to rehabilitation research and care. ^{2 3 5 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for Canadians who have had a stroke. It focuses on including women and individuals with aphasia, who often face barriers to participating in research. The goal is to optimize recruitment methods to ensure these groups are represented in studies about stroke rehabilitation.

Inclusion Criteria

Adequate language skills to understand Informed Consent and retain information during daily therapies

I have help for daily rehab exercises and rides when needed.

I can move my shoulder slightly without gravity or can visibly move two or more fingers.

Exclusion Criteria

Limited resources or illness that will not enable a return to living outside of a facility

I had some disability before my stroke.

History of dementia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 days to 8 weeks

Recruitment and Enrollment

Participants are approached and provided with either traditional or women-centred, aphasia-friendly recruitment materials to decide on trial participation

Up to 8 weeks

Multiple interactions with Site Coordinator

Treatment

Participants receive Maraviroc or placebo combined with 8 weeks of rehabilitation to improve motor and sensory function

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

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

Trial Overview The study compares two different ways of recruiting participants: ORDER, which supports women and people with aphasia, making the process easier for them; and TRAD, the traditional way of enrolling people into trials. The aim is to see which method works better for equitable inclusion.

Participant Groups

Group I: Traditional recruitment and enrollment processes (TRAD) Experimental Treatment 1 Intervention

Traditional participant information letter and consent form only (TRAD)

Group II: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

In a pilot study involving 62 participants with post-stroke aphasia, speech-language telerehabilitation delivered via videoconference showed significant improvements in repetition and sentence production scores compared to usual care alone, indicating potential efficacy in language rehabilitation.

No adverse events were reported during the study, suggesting that telerehabilitation is a safe intervention; however, a larger definitive trial with 230 participants is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial. Øra, HP., Kirmess, M., Brady, MC., et al.[2022]

A systematic review of aphasia research datasets revealed significant gaps in participant and intervention details, with only 25.8% of studies reporting prior stroke information and just 2.3% providing socio-economic status, which are crucial for understanding treatment outcomes.

While basic participant demographics like age and sex were commonly reported, the lack of detailed intervention descriptions limits the ability to replicate studies and apply findings in clinical practice, highlighting the need for improved reporting standards in aphasia research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating simply, but not too simply: Reporting of participants and speech and language interventions for aphasia after stroke. [2022]

The pilot randomized controlled trial (RCT) successfully recruited 42 participants with post-stroke aphasia, achieving an 83% retention rate, indicating that the SPA intervention is feasible for a larger study.

Participants found the singing groups acceptable and manageable, with high attendance and adherence to the intervention, suggesting that a definitive RCT could effectively assess the impact of the SPA intervention on well-being and social participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility. Tarrant, M., Carter, M., Dean, SG., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Communicating simply, but not too simply: Reporting of participants and speech and language interventions for aphasia after stroke. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

People with aphasia: capacity to consent, research participation and intervention inequalities. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Priorities for Closing the Evidence-Practice Gaps in Poststroke Aphasia Rehabilitation: A Scoping Review. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Are People with Aphasia Included in Stroke Trials? A Systematic Review and Narrative Synthesis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Supporting people with post-stroke aphasia to live well: A cross-sectional survey of Speech & Language Therapists in Ireland. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility. [2021]