Active — Not RecruitingNot Applicable

Arm and Leg Cycling for Accelerated Recovery From SCI

United States5 participantsStarted 2023-01-23

Plain-language summary

The purpose of this study is to examine the ability of simultaneous motorized upper and lower extremity cycling training to regulate spinal movement patterns in order 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 motorized cycling.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Traumatic 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 fully engaging in study procedures * MRI contraindications: * Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps * Metal in the body (rods, plates, screws, shrapnel, dentures, metal IUD, etc) * Surgical clips in the head or previous neurosurgery * Cochlear implants * Prosthetic heart valves * Claustrophobia * Tremor * TMS contraindications * Epilepsy or any other type of seizure history * Medications that increase the risk of seizures * Non-prescribed drug or marijuana use * Depression, antidepressant medications…

What they're measuring

Change in 10-meter walking test (10MWT)

Timeframe: 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.

Change in 6-minute walking test (6MWT)

Timeframe: 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.

Trial details

NCT IDNCT05619146

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-31

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in 10-meter walking test (10MWT)

Timeframe: 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.

Change in 6-minute walking test (6MWT)

Timeframe: 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.