Arm and Leg Cycling for Spinal Cord Injury

Overseen By Grace W Hoo, MS

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, Heart disease, Seizure history, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals with incomplete spinal cord injuries improve their walking ability. It tests three approaches: arm and leg cycling with electrical stimulation, cycling with added spinal cord stimulation, and traditional body weight-supported treadmill training. The goal is to determine which method best aids walking recovery. Ideal participants have had a spinal cord injury for at least a year, can walk with some assistance, and can cycle with their arms for 15 minutes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation methods for spinal cord injuries.

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 are taking antidepressant or antipsychotic medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both arm and leg cycling, along with transcutaneous spinal cord stimulation (tSCS), are generally safe for people with spinal cord injuries. Participants typically find arm and leg cycling easy to manage. Studies suggest that tSCS is safe and effective for improving walking and movement. Most participants experience a strong but manageable sensation from tSCS, without unwanted muscle movements. These findings offer promise for those considering joining a trial with these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injury because they explore new ways to enhance mobility and sensation. The Arm and Leg Cycling with Functional Electrical Stimulation (FES) combines voluntary movement with electrical stimulation to boost muscle activity and proprioceptive feedback, which is different from traditional therapies like physical therapy alone. The Arm and Leg Cycling with transcutaneous spinal cord stimulation (tSCS) adds another layer by using electrical currents to stimulate the spinal cord, which might improve nerve function without invasive surgery. These innovative approaches aim to mimic natural walking patterns and potentially offer more significant improvements than current methods, making them promising options for those with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

This trial will compare different interventions for spinal cord injury rehabilitation. One group will receive arm and leg cycling combined with transcutaneous spinal cord stimulation (tSCS), which research shows can improve walking in people with spinal cord injuries. Combining tSCS with exercises like cycling can boost physical ability and aid leg movement recovery by stimulating the spinal cord to enhance muscle function and coordination. Previous studies have reported better leg movement and walking ability with this approach. Another group will receive arm and leg cycling with functional electrical stimulation (FES) but without active tSCS. Additionally, a separate group will undergo body weight supported treadmill training (BWSTT) as a control intervention. These findings suggest that these approaches might help people with incomplete spinal cord injuries regain more mobility. ^{1 2 4 5 6}

Who Is on the Research Team?

Jose L Pons, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals with an incomplete spinal cord injury who are looking to improve their walking function. Specific eligibility criteria were not provided, so interested participants should contact the study organizers for more information.

Inclusion Criteria

I have partial paralysis affecting my limbs.

It has been over a year since my injury.

I can walk by myself for 30 feet, even with aids or braces.

Exclusion Criteria

Pregnancy

Prisoners

My weight is over 160 kg (352 lbs).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo interventions with arm and leg cycling, with or without functional electrical stimulation and transcutaneous spinal cord stimulation, or control body weight supported treadmill training

12 weeks

Weekly visits for intervention and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic assessments at 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Arm and Leg Cycling
• Body Weight Supported Treadmill Training

Trial Overview The study is testing three interventions: arm and leg cycling (A&L cycling), A&L cycling with functional electrical stimulation (FES), and A&L cycling with FES plus transcutaneous spinal cord stimulation (tSCS). The control group will undergo body weight supported treadmill training (BWSTT).

How Is the Trial Designed?

Group I: A&L_tSCS group Experimental Treatment 1 Intervention

This paradigm combines A\&L\_FES with transcutaneous spinal cord stimulation (tSCS)applied with cathodic electrodes at the C3-C4 and C6-C7 spinous processes and anodic electrodes at the iliac crests. The stimulation intensity is set to trigger a spinal evoked potential, ensuring a strong but tolerable sensation at the cathode sites without evoking direct motor responses in the arm or leg EMG.

Group II: BWSTT group Active Control 1 Intervention

This is the control intervention. Participants will first be assisted by physical therapists/trainers to wear any necessary lower extremity braces along with a padded walking harness. They will then be helped onto the treadmill, either from a wheelchair via a ramp or by walking with physical assistance. Once on the treadmill, they will be clipped into the body weight support system, assisted to a standing position, and provided with the appropriate level of body weight support to facilitate successful stepping.

Group III: A&L_FES group Placebo Group 1 Intervention

This paradigm uses a commercially available motorized ergometer that link the arms \& legs mechanically to support voluntary arm and leg cycling and provide reciprocal movements that resemble those during walking. FES is used to assist the the voluntary leg movements, which also enhances proprioceptive feedback. Specifically, functional electrical stimulation (FES) is applied to the major muscles of both legs-including the quadriceps, hamstrings, and gluteus maximus-using pairs of surface electrodes. For sham transcutaneous spinal cord stimulation (tSCS), electrodes will be placed but no tSCS current will be delivered.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study of 2,213 full-time wheelchair users with spinal cord injuries, nearly 45% experienced wheelchair repairs within six months, and 8.7% faced adverse consequences from breakdowns, highlighting a significant issue for this population.

Power wheelchair users had a notably higher frequency of repairs and adverse consequences compared to manual wheelchair users, indicating that the type of wheelchair may influence reliability and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. McClure, LA., Boninger, ML., Oyster, ML., et al.[2015]

Arm cycle ergometry training for five weeks significantly improved maximal oxygen consumption by 60.54% in four male subjects with spinal cord injuries, indicating enhanced aerobic capacity.

While there were also increases in maximal work loads (64.32%), only the improvement in oxygen consumption was statistically significant, likely due to the small sample size and variability among subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of arm ergometry training on physical work capacity of individuals with spinal cord injuries. DiCarlo, SE., Supp, MD., Taylor, HC.[2019]

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

Case report: Virtual reality-based arm and leg cycling ... The use of Virtual Reality-based arm and leg cycling along with transcutaneous electrical spinal cord stimulation has potential to positively impact function ...

2. withpower.com withpower.com/trial/phase-spinal-cord-injuries-3-2024-b3813

Spinal Cord Stimulation + Arm Bike for Spinal Cord Injury Research shows that arm cycle ergometry, a component of this treatment, can significantly improve physical work capacity in individuals with spinal cord ...

3. researchgate.net researchgate.net/publication/381118382_Case_report_Virtual_reality-based_arm_and_leg_cycling_combined_with_transcutaneous_electrical_spinal_cord_stimulation_for_early_treatment_of_a_cervical_spinal_cord_injured_patient

(PDF) Case report: Virtual reality-based arm and leg ... The use of Virtual Reality-based arm and leg cycling along with transcutaneous electrical spinal cord stimulation has potential to positively impact function ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01545-8

Transcutaneous spinal cord stimulation combined with robotic ... The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06313515

NCT06313515 | Transcutaneous Spinal Cord Stimulation ... The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/15/1/e089756

Short- and long-term effects of transcutaneous spinal cord ... This study aims to explore the efficacy of acute TSCS for restoring autonomic function at rest and during arm-crank exercise to exhaustion.