Rapid early mobilization with seated cycling for people with recent traumatic spinal cord injury (PROMPT-SCI II)
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial: Initiating Early Acute Cycling Within the First Days After Spinal Cord Injury to Decrease Complications and Improve Neurofunctional Recovery
NA · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · NCT07472985
This study will test whether starting seated cycling within days after a traumatic spinal cord injury is safe and helps improve recovery and reduce complications in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07472985 on ClinicalTrials.gov |
What this trial studies
PROMPT-SCI II is a single-center longitudinal cohort study that starts seated cycling early during acute care to see if longer-duration, upright cycling improves neurofunctional recovery and lowers immobilization complications. Participants are adults with non-penetrating traumatic SCI (AIS A–C) with neurological level C0–L2 who had spine surgery within 48 hours and are medically stable for cycling. The intervention is activity-based seated cycling begun in the first days after injury and continued through acute hospitalization, with monitoring for adverse events and completion rates. Outcomes include safety, complication rates, and measures of motor and sensory recovery compared to expected recovery trajectories.
Who should consider this trial
Good fit: Adults (18+) with recent non-penetrating traumatic spinal cord injury (AIS grades A–C) affecting levels C0–L2 who had spine surgery within 48 hours and are medically stable for seated cycling are ideal candidates.
Not a fit: Patients who are intubated or mechanically ventilated, medically unstable, have moderate-to-severe traumatic brain injury, weight-bearing or mobilization restrictions, or other conditions that prevent safe cycling are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, early seated cycling could reduce complications from immobilization and help improve neurological recovery and independence after traumatic SCI.
How similar studies have performed: A prior PROMPT-SCI study showed early in-bed cycling was safe, reduced some complications, and activated paralyzed muscles but did not demonstrate neurofunctional benefit, while preclinical studies suggest early exercise can aid recovery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Jean-Marc Mac-Thiong, MD, PhD — Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study coordinator: Jean-Marc Mac-Thiong, MD, PhD
- Email: jean-marc.mac-thiong@umontreal.ca
- Phone: 514-338-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Spinal Cord Injury, Initial Encounter, spinal cord injury, exercise, activity-based therapy, rehabilitation, complications, acute care