NCT07472985 Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial

Eligibility & Interventions

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This trial targets 102 participants in total. It began in 2026-03-09 with a primary completion date of 2031-08-31.

Brief Summary

Spinal cord injuries (SCI) are among the most catastrophic survivable events experienced by human beings. Affected individuals remain with lifelong neurological impairment involving motor, sensory, bladder and bowel functions, which in turn impacts quality of life and independence. Currently, patients have no access to exercise therapy for weeks to months after the injury because clinicians remain fearful that early initiation of exercise therapy may be harmful to patients, and could lead to neurological deterioration. Patients are therefore mostly immobilized during the first weeks after the injury, and are at high risk of complications associated with immobility. In addition, there are compelling preclinical evidence showing that early exercise therapy is effective for promoting neurofunctional recovery. The PROMPT-SCI trial was the first to initiate early exercise therapy in the form of in-bed leg cycling within days after SCI. This trial has shown that it is safe and does not lead to neurological deterioration. However, in-bed leg cycling remains difficult to translate into the clinical environment of acute SCI, and its potential to decrease complications and improve neurofunctional recovery seems limited by the positioning in bed. The PROMPT-SCI II trial will therefore evaluate the potential of sitting leg cycling initiated within the first week of a SCI to decrease complications and improve neurofunctional recovery up to one year after the injury, in comparison to our prior data obtained with early in-bed cycling.

Eligibility Criteria

Inclusion Criteria: * adults 18 years or older with non-penetrating traumatic SCI * SCI severity AIS grade A (complete injury with no motor or sensory function below lesion), B (sensory but no motor function preserved) or C (motor function preserved with most key muscles unable to move against gravity) * NLI between C0 and L2; and spine surgery performed within 48 hours of SCI Exclusion Criteria: * intubated and mechanically ventilated * conditions interfering with patient safety or ability to undergo cycling * body mass index 40 kg/m2 or less (to prevent "frog leg" position during cycling) * moderate or severe traumatic brain injury * hemodynamic instability * pelvic or lower extremity * injury with weight-bearing or mobilization restrictions

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