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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine interventions with paradigms involving upper and lower extremity cycling (A\&L cycling) with A\&L cycling with functional electrical stimulation (FES) (A\&L_FES group), A\&L cycling with FES and transcutaneous Spinal Cord Stimulation (A\&L_tSCS group), and control Body Weight Supported Treadmill Training (BWSTT) 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 these interventional groups.

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.

What data supports the effectiveness of the treatment Arm and Leg Cycling, Body Weight Supported Treadmill Training for Spinal Cord Injury?

Research shows that combining arm and leg cycling significantly improves walking speed and distance in people with incomplete spinal cord injury compared to leg cycling alone. This approach enhances muscle strength, sensation, and balance, suggesting that involving both arms and legs in rehabilitation can lead to better walking performance. ^{1 2 3 4 5}

Is arm and leg cycling safe for people with spinal cord injury?

Research on passive leg cycling for people with spinal cord injury shows it can be safe and beneficial, improving blood flow, muscle function, and joint movement without significant safety concerns reported. ^{2 6 7 8 9}

How does the Arm and Leg Cycling treatment differ from other treatments for spinal cord injury?

Arm and Leg Cycling is unique because it involves simultaneous movement of both arms and legs, which enhances walking performance more than leg-only cycling. This approach leverages the interaction between arm and leg movements to improve neural regulation and walking capacity, offering greater benefits than traditional gait-specific training. ^{1 2 3 10 11}

Research Team

Jose L Pons, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

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

Impact of Passive Leg Cycling in Persons With Spinal Cord Injury: A Systematic Review. [2020]

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

Effect of arm ergometry training on physical work capacity of individuals with spinal cord injuries. [2019]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Afferent electrical stimulation during cycling improves spinal processing of sensorimotor function after incomplete spinal cord injury. [2018]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Outcomes of a home cycling program using functional electrical stimulation or passive motion for children with spinal cord injury: a case series. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Maintenance of cutaneomuscular neuronal excitability after leg-cycling predicts lower limb muscle strength after incomplete spinal cord injury. [2017]

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

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Improved work capacity but unchanged peak oxygen uptake during primary rehabilitation in tetraplegic patients. [2019]

11. 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]