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

Table 2 Schedule of data collection

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

ISSN: 1471-2377