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Official Study Title: ENGAGE Pilot Study: Promoting Participation and Health After Stroke ClinicalTrials.gov ID: NCT04019275 Document Date: February 16, 2021100 Technology Drive Bridge side Point

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Clearly outline the objectives and hypothesis of the pilot study.

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Design the study protocol including inclusion and exclusion criteria, randomization procedure, and outcome measures.

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Obtain ethical approval from relevant regulatory bodies.

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Recruit and consent eligible participants.

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Randomize participants into treatment groups.

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Summarize findings and draw preliminary conclusions.

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Researchers who want to test the feasibility and acceptability of a new intervention or study design.

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Healthcare professionals looking to gather preliminary data before conducting a larger randomized controlled trial.

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What is open randomized pilot study?

Open randomized pilot study is a study design in which participants are randomly assigned to different treatment groups with the results being made available to all involved parties.

Who is required to file open randomized pilot study?

Researchers or organizations conducting the study are required to file the open randomized pilot study.

How to fill out open randomized pilot study?

Open randomized pilot study can be filled out by providing detailed information about the study design, participants, treatments, outcomes, and any other relevant data.

What is the purpose of open randomized pilot study?

The purpose of open randomized pilot study is to evaluate the effectiveness and safety of a treatment in a controlled setting before proceeding to larger scale studies.

What information must be reported on open randomized pilot study?

Information such as study design, participant demographics, treatment details, outcomes, and any adverse events must be reported on open randomized pilot study.

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