Status:
ENROLLING_BY_INVITATION
Arm and Leg Cycling for Accelerated SCI Recovery
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
University of Alberta
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to examine interventions with paradigms involving upper and lower extremity cycling (A\&L cycling) with A\&L cycling with functional electrical stimulation (FES) (A\&L\_FE...
Detailed Description
Spinal cord injury (SCI) occurs at an annual rate of 50-60 per million in North America. Paralysis is also accompanied by drastic changes in independence and quality of life. SCI occurs mostly among y...
Eligibility Criteria
Inclusion
- Traumatic or non-traumatic SCI T11 and above (upper motorneuron lesion)
- Incomplete paraplegia or tetraplegia (Classified as AIS C or D)
- Age range 18-75 years old, inclusive
- At least 1 year post- injury
- Independent ambulator (with normal assistive devices or bracing) for at least 10 meters (30 feet)
- Walking speed \<0.8 m/s (2.62 ft/s) (or per researcher discretion)
- Bilateral arm strength to arm cycle at least 15 minutes without assistance (or per researcher discretion)
- No concurrent or planned surgeries, significant medical treatments, or therapy during the study period
- Able to understand and speak English
Exclusion
- SCI T12 and below (or lacking upper motorneuron injury)
- Complete paraplegia or tetraplegia (classified as AIS A)
- AIS B incomplete paraplegia or tetraplegia
- Presence of progressive neurologic disease
- Unable to give informed consent to participate in the study
- Significant other disease (ex: cardiological or heart disease, renal, hepatic, malignant tumors, mental or psychiatric disorders) that would prevent participants from fullym engaging in study procedures
- Weight over 160 kg (352 lbs)
- TMS contraindications
- Epilepsy, seizure disorder, or any other type of seizure history
- Medications that increase the risk of seizures
- Metal or metal fragments in the head (plates, screws, etc.)
- Surgical clips in the head or previous neurosurgery
- Implants in the head (ex: cochlear implants)
- Non-prescribed drug or marijuana use
- Depression, antidepressant medications, or antipsychotic medications
- FES and tSCS contraindications
- Active Deep Vein Thrombosis (blood clot)
- Active infection in the legs
- Open wounds, rashes, or infection at the electrode sites
- Cancer or recently radiated tissue
- Cardiac pacemakers or neurostimulators
- Hypersensitivity to or inability to tolerate electrical stimulation
- Lower motor neuron injury or peripheral nerve injury in the legs that would prevent the muscles from responding to electrical stimulation
- Pregnancy
- Prisoners
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06873776
Start Date
December 1 2025
End Date
September 1 2032
Last Update
May 23 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611