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NCT07798310
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury III (PROMPT-SCI III) Trial
Conditions: Spinal Cord Injuries, Incomplete
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 107
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Location: Hopital du Sacre-Coeur de Montreal Montreal Quebec
Summary
This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality of life one year after the SCI, while decreasing complications during acute care and reducing the care burden (shorter hospital stay and home discharge more likely). For this study, 107 participants with mild SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. Neurofunctional recovery, quality of life, acute complications and care burden for the participants performing early acute cycling will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care.
Eligibility Criteria
Inclusion Criteria:
* adults 18 years or older with non-penetrating traumatic SCI
* SCI severity AIS grade D (motor function preserved with most key muscles able 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
Source: ClinicalTrials.gov (NCT07798310). StuddyBuddy aggregates publicly available trial information.