|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