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.