Activity-Based Therapy for Spinal Cord Injury
(PROMPT-SCI II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jean-Marc Mac-Thiong, MD, PhD
Principal Investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acute Care and Treatment
Participants perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling
Follow-up
Participants are monitored for neurofunctional recovery and complications up to 1 year post-SCI
What Are the Treatments Tested in This Trial?
Interventions
- Activity-Based Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
leg cycling
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
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