Actively Recruiting
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in Adults With Spinal Cord Injury
Led by Dr. B. Catharine. Craven · Updated on 2026-05-14
6
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
Sponsors
D
Dr. B. Catharine. Craven
Lead Sponsor
C
CAN-TAP-TALENT (CIHR Stream)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new exercise approach to help reduce cardiometabolic disease (CMD) risk in adults with chronic spinal cord injury or disease (SCI/D). CMD is a major cause of death in this group, often presenting suddenly as heart attacks or strokes. Due to challenges like limited mobility and difficulty exercising, new accessible and safe strategies are urgently needed to address CMD risk factors in this population. The study evaluates the safety and feasibility of combining functional electrical stimulation cycling (FES-Cycling) with blood flow restriction (BFR) exercise. Participants will complete eight exercise sessions over six weeks, including four sessions of FES-Cycling alone and four sessions of FES-Cycling with BFR. Each session involves 20 minutes of moderate-intensity exercise using special devices that stimulate leg muscles and restrict blood flow to enhance exercise benefits. Participants will attend two testing sessions before and after the exercise period, during which researchers will monitor safety including skin checks, heart rate, blood pressure, oxygen levels, and discomfort. They will also track recruitment, retention, and changes in cardiometabolic risk factors such as lipid profile and blood glucose. Participant feedback will help guide future exercise program development. The total study duration for each participant is six weeks.
CONDITIONS
Brief Title
FES Cycling With BFR in the Spinal Cord Injury Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 to 75 years
- Male or female
- Chronic spinal cord injury for more than 1 year
- Diagnosis of spinal cord injury at levels C5 to T10 with AIS A-D classification
- Presence of three or more cardiometabolic risk parameters
You will not qualify if you...
- History of venous thromboembolism
- Pressure injury on pelvis, mid to upper thigh, or foot
- Current lower limb fracture
- History of embolic stroke or myocardial infarction
- Untreated hypertension
- Language, psychiatric, cognitive, or communication disability affecting study participation
- Current alcohol or street drug use disorder
- Use of anticoagulant medication
- Frequent autonomic dysreflexia episodes unresponsive to therapy
- Unresolved deep vein thromboembolism in past six months
- Severe spasticity preventing cycling range of motion
- Presence of active implantable medical device (e.g., pacemaker)
- Inability to provide informed consent
- Severe active medical conditions such as skin or respiratory infections
- Unstable spine or unhealed limb or pelvic fractures
- Active heterotopic ossification interfering with leg movement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants complete two types of exercise sessions: Functional Electrical Stimulated Cycling (FES-Cycling) alone and FES-Cycling with Blood Flow Restriction (BFR).
8 exercise sessions over 6 weeks (twice a week)
Trial Site Locations
Total: 1 location
1
Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Actively Recruiting
Research Team
T
Thomas P Walden, Ph.D
K
Katherine Chan, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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