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

BACKGROUND: A severe traumatic spinal cord injury (SCI) leads to permanent sensorimotor neurological deficits. During acute care, patients are mostly immobilized due to pain (from injuries and surgeries) and inherent paralysis from the SCI, resulting in complications such as pneumonia, pressure injuries, deconditioning, etc. There is also compelling preclinical evidence showing that early immobilization after SCI impairs the capacity of the nervous system to reorganize and promote neurological recovery. The PROMPT-SCI trial was the first to perform a clinical trial of early acute exercise therapy in the form of in-bed leg cycling starting within 5 days of a SCI, leading to these findings: 1) no adverse events associated with cycling, 2) decreased rates of complications, and 3) activation of paralyzed muscles triggered by cycling. Unfortunately, the PROMPT-SCI trial failed to demonstrate neurofunctional benefits similar to those observed in preclinical studies, potentially due to the short 2-week duration of the intervention, and to insufficient tactile and proprioceptive feedback in lower extremities with in-bed cycling, which could be circumvented by performing seated cycling throughout the entire acute care.

GOALS: This longitudinal cohort study will investigate the feasibility and clinical benefits of early acute seated cycling on neurofunctional recovery and complications. The hypotheses are:

H1: There will be no serious adverse events; 80% of participants will complete a first session within 5 days of the SCI and at least 80% of all planned sessions thereafter.

H2: Complication rates will be decreased for pneumonia, urinary tract infection and pressure injuries.

H3: Neurofunctional recovery will be improved 1 year after the SCI.

The specific aims are:

Aim 1: Assess the feasibility of performing early seated cycling throughout acute care.

Aim 2: Assess the complication rates and neurofunctional recovery up to 1 year post-SCI.

METHODS: For this 5-year study, 102 participants with severe acute traumatic SCI (paralyzed lower extremities without anti-gravity strength) will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling. Adherence to protocol, complications and neurofunctional recovery (motor/sensory recovery, functional independence, spasticity) will be assessed up to 1 year post-SCI. Neurophysiological and biomechanical responses to cycling will be assessed from electromyographic and plantar pressure measurements. Outcomes will be compared to our control cohort of patients with severe SCI who have not received exercise therapy. The association between neurophysiological/biomechanical responses and outcomes will be assessed.

• Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8 [Срок оценки: 1 year]
• Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year [Срок оценки: 1 year]
• Total score of Spinal Cord Independence Measure ranging from 0 to 100 [Срок оценки: 1 year]
• Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4 [Срок оценки: 1 year]
• Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3 [Срок оценки: 1 year]
• Presence or absence of neuropathic pain [Срок оценки: 1 year]
• Physical component score from Short-form 36 ranging from 0 to 100 [Срок оценки: 1 year]
• Presence or absence of improvement in motor score by 5 points from baseline to 1 year [Срок оценки: 1 year]
• Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year [Срок оценки: 1 year]
• Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year [Срок оценки: 1 year]
• Mental component score from Short-form 36 ranging from 0 to 100 [Срок оценки: 1 year]