An interventional study of Cycling in Spinal Cord Injuries, Incomplete, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Treatment
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.
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 107 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive daily 30-minute continuous sessions of leg cycling in seated position throughout acute care, starting after surgery as soon as the patient is fit for cycling. While the participant is seated in the armchair in the hospital room, a motorized under desk exerciser will be placed on the floor so that the feet are positioned comfortably on the pedals. The exerciser will be positioned to ensure that maximal knee flexion during cycling will be 70 degrees. Pedal straps are installed to secure the feet while pedaling. Running shoes are provided to participants to prevent harmful pressure and/or friction on heels, and the risk of developing pressure injuries. Participants will pedal at a target cadence of 40 revolutions per minute (RPM).Unless participants actively reach the target cadence of 40 RPM, motor assistance will be noted and titrated/adjusted by the research assistant until the target is reached.
Device: Cycling
Seated cycling using motorized under desk exerciser
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
Time frame: 1 year
Complications
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
Time frame: perioperatively/periprocedurally
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
Time frame: 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
Time frame: 1 year
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
Time frame: 1 year
Presence or absence of neuropathic pain
International Spinal Cord Injury Pain Basic Data Set
Time frame: 1 year
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)
Physical component of Health-related quality of life
Time frame: 1 year
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)
Mental component of Health-related quality of life
Time frame: 1 year
Presence or absence of improvement in motor score by 5 points from baseline to 1 year
Difference in motor score from baseline to 1 year
Time frame: 1 year
Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year
Difference in sensory scores between baseline and 1 year
Time frame: 1 year
Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year
Difference in neurological level of injury between baseline and 1 year
Time frame: 1 year
Plan to share: No — The IPD collected for the study are not publicly available. However, IPD will be made available to others upon reasonable request, and with permission from our Ethics committee.
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal