Context: Activity-based therapy initiated within days of the accident could prevent complications and improve neurofunctional outcomes in patients with traumatic spinal cord injury (TSCI). However, it has never been attempted in humans with TSCI because of practical obstacles and potential safety concerns. The PROMPT-SCI trial is the first attempt at implementing ABT within the first days following a TSCI (i.e. very early ABT; VE-ABT). The objective is to determine if VE-ABT can be initiated safely in the intensive care unit (ICU) within 48 h of early decompressive surgery.
Design: As part of the PROMPT-SCI trial, 15 adult patients with severe TSCI were enrolled between April and November of 2021. The intervention consisted of 30-minute sessions of motor-assisted in-bed leg cycling starting within 48 h of early spinal surgery. Safety was assessed through continuous monitoring of vital signs and recording of adverse events during and after sessions. The main outcome measure was the achievement (yes or no) of a full and safe session within 48 h of early surgery.
Findings: Out of the 15 participants, 10 (66.6%) achieved this outcome. Out of the remaining 5, 2 were not cleared to engage in cycling within 48 h of surgery and 3 initiated cycling within 48 h but stopped prematurely. All 5 eventually completed a full and safe session within the next 1-2 days. In all 15 participants, there were no neurological deteriorations after the first completed session.
Conclusion: Our results suggest that it is safe and feasible to perform a first session of VE-ABT within days of a severe TSCI with no serious adverse events and excellent completion rates.
Keywords: Clinical trial; Early mobilization; In-bed exercise; Spinal cord injury; Traumatology.