FES-Cycling With Blood Flow Restriction for SCI/D Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety and practicality of combining FES-Cycling with blood flow restriction in people with spinal cord injury. Eligible adults with chronic SCI (C5–T10) and multiple cardiometabolic risk factors will participate in a structured, moderate-intensity aerobic program using FES-assisted cycling while cuffs modestly restrict blood flow. Researchers will monitor safety, tolerability, and feasibility, including adverse events and adherence, to inform future efficacy studies. The study builds on preliminary data suggesting BFR can enhance muscle burden and metabolic responses in SCI/D patients. The trial is conducted at the Lyndhurst Centre in Toronto, led by Dr. B. Catharine Craven, with CAN-TAP-TALENT collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult (≥ 18 to ≤ 75yrs)
* Male or female
* Chronic Injury (\>1yr)
* Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.
* ≥3 Cardiometabolic risk parameters

Exclusion Criteria:

* A prior or current history of venous thromboembolism
* Pressure injury of the pelvis, mid to upper thigh region, or foot
* Managing a lower limb fracture
* Any history of embolic stroke
* Myocardial infarction
* Current untreated hypertension
* Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and/or operate the device.
* Current alcohol or street drug use disorder.
* Current use of an anticoagulant medication.
* Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).
* Unresolved deep vein thromboembolism (VTE) in the past six months.
* Severe spasticity preventing the necessary range of motion for cycling.
* Active implantable medical device (e.g., pacemaker, ITB pump).
* Inability to provide informed consent.
* Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).
* Unstable spine or unhealed limbs or pelvic fractures.
* Active heterotopic ossification interfering with the lower extremity range of motion.

Where it's running

• Lyndhurst Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Thomas P Walden, Ph.D
• Email: thomas.walden@uhn.ca
• Phone: 4165973422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.