Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Ambulation
Study Overview
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 severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Early in-bed leg cycling
Intervention: Leg ergometer (Device)
Outcomes
Primary Outcomes
Ambulation
Time Frame: 6 months
Independent walking (with or without device)
Secondary Outcomes
- Health related quality of life(6 months)
- Neurological recovery(6 months)
- Function(6 months)
- Spasticity(6 months)
Investigators
Jean-Marc Mac-Thiong
Principal Investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal