Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)

University of Louisville, Université de Montréal, The Craig H. Neilsen Foundation, École de technologie supérieure

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

Inclusion Criteria: Blunt traumatic spinal cord injury Neurological level of injury from C0 to L2 American Spinal Injury Association impairment scale grade A, B or C Spine surgery performed within 48 hours of injury Exclusion Criteria: Condition limiting patient's ability to engage into cycling Medical condition that might interfere with patient's safety if cycling Moderate or severe brain injury Inability to walk independently prior to injury Pre-existing neurological disorder Complete spinal cord transection Unwilling or unable to comply with scheduled follow-up

In line with the recommendations from the Committee on strategies for Responsible Sharing of Clinical Trial Data

Mac-Thiong JM, Richard-Denis A, Petit Y, Bernard F, Barthelemy D, Dionne A, Magnuson DSK. Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury. BMJ Open. 2021 Nov 1;11(11):e049884. doi: 10.1136/bmjopen-2021-049884.