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Table 2 Schedule of data collection

From: Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation

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 +
  1. PT: Physical therapy.
  2. () Parentheses indicate that the outcome will be assessed if the participant is able to walk without physical assistance.
  3. aindicates that the measure will be taken or monitored throughout the intervention period