Comparing Functional Electrical Stimulated Cycling with Blood Flow Restriction for spinal cord injury
Official title: FES Cycling With BFR in the Spinal Cord Injury Population
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population
- Phase 1
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medical device
Blood Flow Restriction
Blood Flow Restriction (BFR) exercise is a training method where a specialized cuff or band is applied to the top of a limb (arm or leg) to partially restrict blood flow during exercise.
- Other intervention
Functional Electrical Stimulated Cycling
Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Lyndhurst Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).
- −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.
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Functional Electrical Stimulated Cycling.
Registry label: A: Functional Electrical Stimulated Cycling
Group B, the comparison group, receives Functional Electrical Stimulated Cycling and Blood Flow Restriction.
Registry label: B: Functional Electrical Stimulated Cycling with Blood Flow Restriction
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 6 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: Six weeks - From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the exercise protocolProtocolThe detailed plan a study must follow.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Participant Retention — measured over Six weeks - From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the exercise protocolProtocolThe detailed plan a study must follow.Read more →.
Safety - Skin Checks — measured over 6 weeks.
Safety - Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → Report — measured over 6 weeks.
Recruitment Rate — measured over 2 to 3 months, depending on how successful the recruitment process is.
The study lists 11 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07588503 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Blood Flow RestrictionDevice
Blood Flow Restriction (BFR) exercise is a training method where a specialized cuff or band is applied to the top of a limb (arm or leg) to partially restrict blood flow during exercise.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Functional Electrical Stimulated CyclingOther
Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Six weeks - From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the exercise protocolProtocolThe detailed plan a study must follow.Read more →..
The study as a whole is currently expected to finish around 2027-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 6 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury/disease (SCI/D) population. Many SCI/D patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI/D population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI/D population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI/D population is a compelling and urgent health priority. Blood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the limb, shifting the way the muscles can produce the energy required to function, increasing the benefits of low- and moderate-intensity exercise. Coupling BFR with Functional electrical stimulation cycling (FES-cycling), a commonly used rehabilitation tool within the SCI population, could improve FES-cycling's short- and long-term benefits without reducing the accessibility and inclusiveness of long-term exercise prescription. Although preliminary BFR research in the SCI/D has identified positive muscular improvements, whether FES-cycling coupled with BFR can be safely prescribed or feasibly implemented long-term within the SCI/D population is unknown. The proposed project aims to determine the safety and feasibility of FES-cycling coupled with BFR for 20 minutes of moderate-intensity exercise among adults with chronic spinal cord injury/disease (SCI/D). The research team aims to implement pre-test, eight exercise sessions, and post-test across 6-weeks. Criteria for success include no adverse or severe adverse events not alleviated by ceasing exercise (safety), a 1 to 8 ratio of participants screened to participants eligible (recruitment success), and participants successfully completing all exercise sessions (participant retention).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.