Rapid early mobilization with seated cycling for people with recent traumatic spinal cord injury (PROMPT-SCI II)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.