Table 1

Pre-screening to randomization flow with purpose and time interval
STUDY PHASE EVENT PURPOSE TIME INTERVAL
PRE-SCREENING Express Chart Screen (ECS) Chart review for excludable non-modifiable criteria is performed under IRB-approved HIPAA waiver. Before 106th day post-stroke
SCREENING HIPAA Authorization & Screening Informed Consent (IFC) Prospective Participants (PP’s) who pass Pre-Screen are introduced to the study. A signed HIPAA Authorization & Screening IFC are required to proceed.
Brief Clinical Screen (BCS) An initial brief screen is completed to ensure sufficient motor and cognitive recovery and pre-morbid function for eligibility. If recovery is not sufficient, PP’s may be re-tested up to 106 days post-stroke.
Detailed Clinical Screen (DSC) If BCS is passed, a detailed clinical screen for eligibility is administered. PP’s Primary Care Physician is notified if DCS is passed. Signed HIPAA authorization is included with the notification letter.
STUDY INFORMED CONSENT Study IFC & Consent To Be Videotaped PP’s who pass DSC are informed about the study in greater detail. A signed Study IFC and Consent to be Videotaped define enrollment and are required to proceed.
BASELINE Brief Medical Exam At Baseline (BME) Medical exam releases PP to participate in trial. Rules out interim neurologic event and serves as re-check for severe depressive symptoms. Opportunity for SPI to establish blood pressure, heart rate, weight-bearing and other medical parameters for safe participation.
Baseline Evaluation Confirms UE motor eligibility. Establishes baseline measures for testing hypotheses. Within 72 hours post-BME1 and between 14–106 days post-stroke.
RANDOMIZATION Group Assignment Treatment group assignment ≤ 48 hours post-Baseline and between 14–106 days post-stroke

1Ideally the Baseline Evaluation will occur within 72 hours post-BME (Brief Medical Exam). If more than 72 hours has transpired, participant must be re-cleared of an interceding neurologic event. PP = Prospective participant; ECS = Express Chart Screen; BCS = Brief Clinical Screen; IFC = Informed Consent; DCS = Detailed Clinical Screen; SPI = Site Physician Investigator.

Winstein et al.

Winstein et al. BMC Neurology 2013 13:5   doi:10.1186/1471-2377-13-5

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