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NCT06873776

Arm and Leg Cycling for Accelerated SCI Recovery

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

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\_FES group), A\&L cycling with FES and transcutaneous Spinal Cord Stimulation (A\&L\_tSCS group), and control Body Weight Supported Treadmill Training (BWSTT) to potentially restore functional abilities (i.e., walking) in individuals with an incomplete spinal cord injury. The researchers hypothesize there will be improved walking function following these interventional groups.

Official title: Stimulation-assisted Arm and Leg Cycling for Accelerated Recovery From Spinal Cord Injury

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12

Completion Date

2032-09

Last Updated

2025-05-23

Healthy Volunteers

Conditions

Spinal Cord Injury

Interventions

DEVICE

A&L cycling

Participants will complete simultaneous arms and legs cycling for 60min of active cycling. Targeted exercise intensity is 70-85% of the age-predicted maximum heart rate. Cycling resistance will be modified for continuous challenge. A target speed 10% above the highest speed at which each study participant is able to cycle voluntarily without motor, FES, or tSCS assistance will be selected during the first session and maintained throughout all training sessions. Once a participant can complete 60 minutes of continuous cycling at a specific resistance for two consecutive training sessions, the resistance will be increased to the next setting level at the mid-point of the subsequent session. Upon completion of each session, the physical therapists/researcher will complete skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks.

DEVICE

Body weight supported treadmill training (BWSTT)

The physical therapists/researchers will assist the patient with donning any necessary lower extremity braces and a padded walking harness. The patient will be assisted onto the treadmill via a ramp while seated in a wheelchair or by ambulation with physical assistance, clipped into the body weight support system, assisted to stand, and provided the appropriate amount of body weight support to allow for successful stepping for 60 minutes of active walking. During BWSTT, physical therapists/trainers will adjust treadmill speed or incline and the degree of body weight support to challenge participants. Participants will be instructed to exercise with a targeted intensity of 70-85% of the age-predicted maximum heart rate. Upon completion of each session, the harness will be doffed with skin checks to ensure no adverse effects have occurred. Heart rate, blood pressure, and oxygen saturation will be recorded. Participants will complete 3 training sessions per week for 12 weeks.

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

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States