Table 1 Timeline for Consent, Screening Processes and Assessments up to Randomization

5–30 days post-stroke

HIPAA Waiver Screen

Chart review for diagnosis, age, medical co-morbidities, life expectancy, discharge distance from clinical site

HIPAA Authorization

Patient grants permission for study staff to complete a comprehensive chart review

Chart Review

Demographics collected, inclusion and exclusion criteria reviewed

Screening Informed Consent

Study staff review screening procedures, risks and benefits

Participant/family interview

Study staff determine:

• Pre-morbid functional status

• Enrollment in another clinical trial

• Ability to attend therapy 3×/week

Physical and Cognitive

Study staff complete tests:

Screen

• 3-Step Command

• Sitting Balance

• Ability to walk 10 feet

• 10 meter walk test (when able)

• Functional Ambulation Category

• Fugl-Meyer Motor and Sensory Tests

• PHQ-9 Depression Scale

• ROM of Lower Extremities

• Contracture Assessment of Lower Extremities

• MMSE

• SF-36 Physical Function

• Pre-morbid Barthel Index

• Orpington Prognostic Scale

• Modified Rankin Index

MD Approval

Confirmation by treating physician that patient meets inclusion/exclusion criteria and is safe for the study

6 – 7 weeks post-stroke

6-Week Phone Contact

Interview confirms continued eligibility

8 weeks post-stroke

Gait Velocity Re-check

10 meter walk test – confirm velocity <.8 m/s

Intervention Informed Consent

Study staff review exercise tolerance test and intervention procedures, risks, and benefits

Exercise Tolerance Test

Cardiologist approves eligibility

Lesion Analysis

Study neurologist reads MRI or CT to characterize lesion

2 months post-stroke

Baseline Assessment

See Table 2 for assessment tests