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

RecruitingNAAges 18 Years - anyAllCentre Integre Universitaire de Sante et Services…
NCT07472985 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • activity-based therapy
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Where

1 site
Hopital du Sacre-Coeur de Montreal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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