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Behavioural Intervention

Recruitment Methods for Stroke Rehabilitation (ORDER-P Trial)

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary ischemic anterior circulation stroke

Age ≥18 years

Must not have

Pre-stroke modified Rankin score ≥2

History of renal insufficiency or creatinine clearance (eGFR) <60mL / min / 1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of decision (consent or decline) for host trial to date of survey or interview

Awards & highlights

No Placebo-Only Group

Summary

This trial focuses on understanding the impact of stroke in Canada and how research studies can help improve rehabilitation treatments. It mentions that certain groups, like women and people with aphasia, are often excluded from stroke

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial tests recruitment strategies rather than medical treatments, there are no direct side effects related to drugs or therapies. However, participants may experience stress or discomfort during the decision-making process about joining the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke affecting the front part of my brain.

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I am 18 years old or older.

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I am receiving inpatient rehab for weakness on one side of my body.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had some disability before my stroke.

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My kidney function is reduced with a creatinine clearance rate below 60 mL/min.

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I am HIV positive.

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I am currently taking specific antifungal or antibacterial medications.

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I am currently taking St. John's Wort.

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I have had seizures caused by a stroke.

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I have a serious condition like Parkinson's or severe injury that was present before my stroke.

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I have epilepsy.

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I am currently taking Carbamazepine, Phenobarbital, or Phenytoin.

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I have had hepatitis or high liver enzymes/bilirubin levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date identified as eligible for the host trial to date of decision (consent or decline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date identified as eligible for the host trial to date of decision (consent or decline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date identified as eligible for the host trial to date of decision (consent or decline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Barriers and facilitators

Feasibility

Preliminary estimates of effect

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Traditional recruitment and enrollment processes (TRAD)Experimental Treatment1 Intervention

Traditional participant information letter and consent form only (TRAD)

Group II: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)Experimental Treatment1 Intervention

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

0 / 14Eligibility criteria met