Arm and Leg Cycling for Spinal Cord Injury

Overseen By Grace Hoo, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Antidepressants, Antipsychotics, Seizure-risk drugs

Disqualifiers: Complete paraplegia, Progressive neurologic disease, Significant other disease, MRI contraindications, TMS contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether motor-assisted cycling for both arms and legs can help individuals with incomplete spinal cord injuries improve their walking abilities. Researchers believe this exercise might enhance control over spinal movements, potentially leading to better walking. It suits individuals who have sustained a spinal cord injury at the T11 level or higher, can walk at least 30 feet with assistance, and can cycle with their arms for 15 minutes unaided. As an unphased trial, it provides a unique opportunity to explore innovative rehabilitation methods that could enhance the recovery journey.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that increase the risk of seizures or if you are taking antidepressant or antipsychotic medications.

What prior data suggests that motor-assisted arms and legs cycling is safe for individuals with spinal cord injury?

Research has shown that motor-assisted bikes for arms and legs are safe for people with spinal cord injuries. One study found that participants easily handled this type of cycling, and importantly, reported no adverse reactions. This suggests general safety in its use. Other studies have demonstrated that passive leg cycling can improve heart health, muscle strength, and nerve function. Overall, the evidence supports motor-assisted cycling as a safe and beneficial activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about motor-assisted cycling for spinal cord injury (SCI) because it offers a unique approach to rehabilitation. Unlike traditional therapies that may rely heavily on passive stretching or resistance training, this treatment involves motor-assisted cycling, which actively engages both arms and legs. This can potentially improve muscle coordination and circulation in ways other therapies do not. Additionally, motor-assisted cycling can be adjusted to different levels of assistance, making it adaptable for people with varying degrees of injury. This versatility and active engagement make it a promising option for enhancing recovery in SCI patients.

What evidence suggests that motor-assisted arms and legs cycling is effective for spinal cord injury?

Research has shown that motor-assisted cycling, involving both arms and legs, can benefit people with partial spinal cord injuries. Studies have found that repeated sessions of passive leg cycling improve heart health, muscle strength, and nerve function. In this trial, participants will use motor-assisted cycling, which is safe and may enhance walking by coordinating spinal movements. Another study suggested that combining virtual reality with arm and leg cycling boosts brain activity and movement in spinal cord injury patients. Overall, these findings indicate that motor-assisted cycling could be a valuable tool for recovery in people with spinal cord injuries. ^{1 3 6 7 8}

Who Is on the Research Team?

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityL

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-75 with an incomplete spinal cord injury (SCI) at least one year post-injury. Participants must be able to walk 10 meters with or without assistive devices and have a walking speed less than 0.8 m/s. They should have upper body strength to cycle for at least 15 minutes. Those with complete paraplegia, progressive neurological diseases, significant other diseases, or contraindications for MRI/TMS are excluded.

Inclusion Criteria

I have partial paralysis affecting my limbs.

My walking speed is slower than 0.8 meters per second.

I can walk by myself for 30 feet, even with aids like a cane or brace.

Exclusion Criteria

I have complete paralysis from the neck down or waist down.

My spinal cord injury is at T12 or lower without upper motor neuron damage.

I do not have any major health issues that would stop me from participating fully in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo motorized upper and lower extremity cycling training to improve walking function

12 weeks

Visits every 3 weeks for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Motor-assisted arms and legs cycling

Trial Overview The study tests if motor-assisted cycling involving both arms and legs can improve walking function in people with incomplete SCI. It explores whether this exercise regulates spinal movement patterns enough to restore abilities like walking.

How Is the Trial Designed?

Group I: SCI subject Experimental Treatment 1 Intervention

Subject with SCI

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Epidural spinal cord stimulation (eSCS) combined with cycling therapy was found to be safe and well-tolerated in seven participants with complete chronic spinal cord injury, with no adverse events reported, even in individuals up to 58 years old and 17 years post-injury.

All participants were able to achieve active cycling without motor assistance when combining eSCS with conscious effort, indicating that this approach can effectively restore volitional movement and improve motor function in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. Hoover, C., Schuerger, W., Balser, D., et al.[2023]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05619146

Arm and Leg Cycling for Accelerated Recovery From SCI The purpose of this study is to examine the ability of simultaneous motorized upper and lower extremity cycling training to regulate spinal movement patterns.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6368104/

Impact of Passive Leg Cycling in Persons With Spinal Cord ... Multiple sessions of passive leg cycling showed benefits in three categories – cardiovascular, musculoskeletal, and neurological – with medium to large effect ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11140104/

Case report: Virtual reality-based arm and leg cycling ... Virtual Reality-based rehabilitation has been shown to improve SCI patients' motor dysfunction and promote higher levels of brain activation ( ...

4. scholars.northwestern.edu scholars.northwestern.edu/en/publications/comparing-arm-and-leg-cycling-with-motorized-vs-fes-assistance-fo

Comparing Arm and Leg Cycling with Motorized vs. FES ... This preliminary study compares the efficacy of arm and leg cycling with functional electrical stimulation (A&LFES) versus motorized assistance (A&LMOT) in ...

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-11-2022-16aee

Arm and Leg Cycling for Spinal Cord Injury Research shows that motor-assisted cycling, including arm and leg cycling, is generally safe for people with spinal cord injury. In a study with participants ...

6. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/neu.2024.0297

Safety and Feasibility of Early Activity-Based Therapy ... Early activity-based therapy (E-ABT) has the potential to decrease complications and radically improve neurofunctional recovery following traumatic spinal ...

7. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-00997-2

Hybrid high-intensity interval training using functional ... The primary aim of this study was to examine safety and feasibility of the hybrid HIIT protocol, in the form of FES leg cycling combined with ...

8. liebertpub.com liebertpub.com/doi/10.1089/neu.2022.0322

Neuromodulation Through Spinal Cord Stimulation ... Further, motor-assist cycling was well-tolerated without any adverse events. Cycling has the potential to be a safe research assessment and physical therapy ...