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 |