Arm and Leg Cycling for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen byJose L Pons, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

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.

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 am between 18 and 75 years old.

I have partial paralysis affecting my limbs.

It has been over a year since my injury.

+6 more

Exclusion Criteria

Pregnancy

Prisoners

My weight is over 160 kg (352 lbs).

+8 more

Participant Groups

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).

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: A&L_tSCS groupExperimental Treatment1 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 groupActive Control1 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 groupPlacebo Group1 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.