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. 2024 Sep 4;7(9):e2431501. doi: 10.1001/jamanetworkopen.2024.31501

Figure. Participant Flow Diagram.

Figure.

EAW indicates exoskeletal-assisted walking; ITT, intention to treat; and SOC, standard of care control group. Note that the EAW group is labeled “EAW and SOC” but is referred to in analyses as the EAW group.

aThe major reasons for 1 or more screening failures were bone mineral density loss (n = 64), range of motion or spasticity (n = 39), medical contraindications (n = 31), failed EAW basic skills test (n = 32), anthropometric or weight limits (n = 27), fracture history (n = 21), level of spinal cord injury or neurologic status (n = 21), no companion available (n = 15), and other (n = 9).

bThe COVID-19 early administrative withdrawals were participants who were actively enrolled in the study when the pandemic necessitated a study hold and were eventually terminated by the data monitoring committee due to an inability to restart the study.

cThe 4 serious adverse events in the EAW group that resulted in early withdrawals were 2 fractures, including 1 femur fracture that occurred during transfer from wheelchair to toilet (not related) and 1 foot stress fracture (related) diagnosed as a probable preexisting stress fracture reoccurring during EAW; the other 2 serious adverse events were due to substance abuse and a medical issue, both of which were not study related. There were no adverse event–related early terminations in either group.