Arm and Leg Cycling for Accelerated SCI Recovery

Launched by SHIRLEY RYAN ABILITYLAB · Mar 7, 2025

Keywords

ClinConnect Summary

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 younger individuals, half in people 16-30 years of age. Two-thirds of all SCIs are incomplete (iSCI), with some preserved neural connections relaying information to and from the brain. People with iSCI benefit most from improvements in walking. In addition to increasing independence, walking helps persons with iSCI remain active, with a variety of beneficial health-related outcomes. Therapy that...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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

Trial Officials