Arm and Leg Cycling for Spinal Cord Injury

Recruiting in Chicago (>99 mi)

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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is arm and leg cycling safe for people with 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 who had spinal cord injuries, cycling was well-tolerated, and no adverse events were reported, indicating it is a low-risk activity. ^{1 2 3 4 5}

How does motor-assisted arms and legs cycling treatment differ from other treatments for spinal cord injury?

This treatment is unique because it involves simultaneous cycling of both arms and legs, which enhances the connection between the brain and spinal cord, leading to greater improvements in walking ability compared to leg-only cycling. The active involvement of the arms helps modulate the neural pathways, resulting in better muscle coordination and walking performance. ^{3 5 6 7 8}

Research Team

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional output improvement in FES cycling by means of forced smooth pedaling. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Modulation of corticospinal input to the legs by arm and leg cycling in people with incomplete spinal cord injury. [2019]

4. Hungary pubmed.ncbi.nlm.nih.gov

Improving functional electrical stimulation driven cycling by proper synchronization of the muscles. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

Monitoring of spasticity and functional ability in individuals with incomplete spinal cord injury with a functional electrical stimulation cycling system. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Non-gait-specific intervention for the rehabilitation of walking after SCI: role of the arms. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Control of Cycling Limb Movements: Aspects for Rehabilitation. [2017]