Table 1 Study phase flow up to point of randomization
Phase | Event | Purpose | Time Interval |
|---|---|---|---|
Pre-Screening | Chart Review | A search of local stroke databases at each site to determine potentially eligible participants | |
Screening | Participant Eligibility Criteria Checklist | An initial brief questionnaire delivered over the phone | |
Study Informed Consent | Consent for Research Document | Explanation of the study in greater detail and signature by the participant expressing intent to proceed with the study | In-person visit #1 |
Baseline 1 Screening | Clinical Evaluation | Evaluations that do not contribute to eligibility and are only assessed at Baseline 1 screening include: handedness (Edinburgh Handedness Inventory), visual neglect (line bisection test), apraxia Clinical and kinematic outcome measures are assessed | In-person visit #1 |
Research MRI | MRI | MRIa | Any time prior to starting intervention |
Randomization | Group Assignment | Randomization of eligible participant to one of the two intervention arms | Immediately following in-person visit #1 |
Baseline 2 Screening | Clinical Evaluation | Clinical and kinematic outcome measures are assessed to establish consistency with baseline 1 screening | In-person visit #2 |