Status:
COMPLETED
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborating Sponsors:
University of Louisville
Université de Montréal
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a...
Eligibility Criteria
Inclusion
- Blunt traumatic spinal cord injury
- Neurological level of injury from C0 to L2
- American Spinal Injury Association impairment scale grade A, B or C
- Spine surgery performed within 48 hours of injury
Exclusion
- Condition limiting patient's ability to engage into cycling
- Medical condition that might interfere with patient's safety if cycling
- Moderate or severe brain injury
- Inability to walk independently prior to injury
- Pre-existing neurological disorder
- Complete spinal cord transection
- Unwilling or unable to comply with scheduled follow-up
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04699474
Start Date
April 1 2021
End Date
August 31 2024
Last Update
November 26 2025
Active Locations (1)
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1
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5