Spinal Cord Injuries, Incomplete
Conditions
Keywords
spinal cord injury, activity-based therapy, exercise therapy, rehabilitation, acute care
Brief summary
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.
Detailed description
GOALS: This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). Primary hypothesis: Recovering independent walking 1 year after a mild SCI is more likely with early acute exercise therapy, in comparison with a historical cohort not exposed to early acute exercise therapy. An increase in the percentage of individuals recovering independent walking in the community from 35% to 55% will be considered as a clinically meaningful increase. Secondary hypothesis: Acute complications, neurological recovery, functional independence, quality of life and care pathway are improved with early acute exercise therapy. METHODS: For this 5-year study, 107 participants with mild acute traumatic 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. The immediate response to cycling will be monitored from physiological (hemodynamic and respiratory) and electrophysiological (electromyography and H-reflex testing in lower extremities) assessments. Independent walking in the community (primary outcome) is defined by the ability to walk 100 meters outdoors without technical aids or only with leg orthosis. Secondary outcomes include all complications occurring during acute care (particularly early spasticity, pneumonia, urinary tract infection and pressure injury) and the care pathway (discharge destination and length of stay), as well as neurological recovery, functional independence and quality of life 1 year after the SCI. Outcomes will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care, and the association with electrophysiological measures will be assessed.
Interventions
DEVICECycling
Seated cycling using motorized under desk exerciser
Sponsors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective longitudinal cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * hemodynamic instability * pelvic or lower extremity * injury with weight-bearing or mobilization restrictions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 year | Ambulation in the community |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | perioperatively/periprocedurally | 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 | 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) | 1 year | 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) | 1 year | Severity of spasticity |
| Presence or absence of neuropathic pain | 1 year | International Spinal Cord Injury Pain Basic Data Set |
| Physical component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome) | 1 year | Physical component of Health-related quality of life |
| Mental component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome) | 1 year | Mental component of Health-related quality of life |
| Presence or absence of improvement in motor score by 5 points from baseline to 1 year | 1 year | Difference in motor score from baseline to 1 year |
| Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year | 1 year | Difference in sensory scores between baseline and 1 year |
| Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year | 1 year | Difference in neurological level of injury between baseline and 1 year |
Countries
Canada
Contacts
CONTACTJean-Marc Mac-Thiong, MD, PhD
CONTACTAndreane Richard-Denis Richard-Denis, MD, MSc
PRINCIPAL_INVESTIGATORJean-Marc Mac-Thiong, MD, PhD
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Outcome results
None listed