About this trial
This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality of life one year after the SCI, while decreasing complications during acute care and reducing the care burden (shorter hospital stay and home discharge more likely). For this study, 107 participants with mild SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. Neurofunctional recovery, quality of life, acute complications and care burden for the participants performing early acute cycling will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults 18 years or older with non-penetrating traumatic SCI
SCI severity AIS grade D (motor function preserved with most key muscles able to move against gravity)
NLI between C0 and L2; and spine surgery performed within 48 hours of SCI
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Cycling
DeviceSeated cycling using motorized under desk exerciser
Treatment groups
Trial outcomes
Primary outcomes
Score from Item 14 of the Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 8 (a higher score means a better outcome)
Ambulation in the community
Secondary outcomes
Complications
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
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 a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Functional independence
Frequence of spasms from Penn Spasm Frequency Scale ranging from a minimum of 0 to a maximum of 4 (a higher score means a worse outcome)
Severity of spasticity
Sponsors and contacts
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