Table 2.
Study Procedures | Screening | Baseline evaluation | Post-intervention evaluation | Six-month evaluation |
---|---|---|---|---|
Timepoint | -T1 | T0 | T1 | T2 |
Informed consent | + | |||
Inclusion/exclusion criteria | + | |||
Demographics | + | |||
Randomization | + | |||
Primary outcome measure | ||||
Functional Ambulation Category [30] | + | + | + | |
Secondary outcome measures | ||||
Impairment | ||||
Fugl-Meyer Assessment (Lower extremity) [31] | + | + | + | |
Functional | ||||
5-Meter Walk test [32] | (+) | (+) | ||
6-Minute Walk test [33] | (+) | (+) | ||
Berg Balance Scale [34] | + | + | + | |
activPAL mean step count (in PT) | +a | |||
Days to unassisted ambulation | +a | |||
activPAL daily step count over 4 days [35, 36] | + | |||
Cognitive | ||||
Montreal Cognitive Assessment [37] | + | + | + | |
Quality of life | ||||
Patient Health Questionnaire [38] | + | + | + | |
36-Item Short Form Survey [39] | + | + | + | |
Adverse events screen | +a | + |
PT: Physical therapy.
() Parentheses indicate that the outcome will be assessed if the participant is able to walk without physical assistance.
aindicates that the measure will be taken or monitored throughout the intervention period