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 range

18 Years – 75 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 75 Years

Sex

ALL

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.