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NCT06873776

Arm and Leg Cycling for Accelerated SCI Recovery

Enrolling by Invitation
NAAges 18–75InterventionalBasic science
Shirley Ryan AbilityLab
~40 participants
Updated 2025-05-23 on ClinicalTrials.gov
What's tested:A&L cyclingBody weight supported treadmill training (BWSTT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 10-meter walking test (10MWT)
Measured over Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.

Conditions

Spinal Cord Injury

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Jose L Pons, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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

What this trial measures

  • Change in 10-meter walking test (10MWT)Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training.

    The 10-meter walking test (10MWT) is a physical function test measuring the total time to ambulate 10 meters in order to calculate walking speed in meters per second. A shorter time indicates a better walking speed.