Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Leg ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04699474

2020-1901

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Early in-bed leg cycling

Experimental group

Treatment:

Device: Leg ergometer