Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Leg ergometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early in-bed leg cycling<br> | Device: Leg ergometer<br>* Leg cycling in bed using motorized ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation | Independent walking (with or without device) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological recovery | International Standards for Neurological Classification of Spinal Cord Injury | 6 months | 
| Function | Spinal Cord Independence Measure | 6 months | 
| Spasticity | Spinal Cord Assessment Tool for Spastic Reflexes | 6 months | 
| Health related quality of life | Short-form 36 and World Health Organization Quality of Life - BREF | 6 months |