Spinal cord injuries (SCI) are among the most catastrophic survivable events experienced by human beings. Affected individuals remain with lifelong neurological impairment involving motor, sensory, bladder and bowel functions, which in turn impacts quality of life and independence. Currently, patients have no access to exercise therapy for weeks to months after the injury because clinicians remain fearful that early initiation of exercise therapy may be harmful to patients, and could lead to neurological deterioration. Patients are therefore mostly immobilized during the first weeks after the injury, and are at high risk of complications associated with immobility. In addition, there are compelling preclinical evidence showing that early exercise therapy is effective for promoting neurofunctional recovery. The PROMPT-SCI trial was the first to initiate early exercise therapy in the form of in-bed leg cycling within days after SCI. This trial has shown that it is safe and does not lead to neurological deterioration. However, in-bed leg cycling remains difficult to translate into the clinical environment of acute SCI, and its potential to decrease complications and improve neurofunctional recovery seems limited by the positioning in bed. The PROMPT-SCI II trial will therefore evaluate the potential of sitting leg cycling initiated within the first week of a SCI to decrease complications and improve neurofunctional recovery up to one year after the injury, in comparison to our prior data obtained with early in-bed cycling.
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
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
Single group
activity-based therapy
Procedure/SurgeryDaily 30-minute sessions of seated cycling throughout acute care
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse events including changes in blood pressure, heart rate, oxygen saturation, etc.
Complications
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8
Ambulation in the community
Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year
Difference in American Spinal Injury Association Impairment Scale grade between baseline and 1 year
Total score of Spinal Cord Independence Measure ranging from 0 to 100
Functional independence
Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4
Spasm frequency
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
