Robotic & Electrical Stimulation for Spinal Cord Injury

Overseen By Weena Dee, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Unhealed decubiti, Severe cardiovascular disease, Others

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining robotic pelvis training with electrical stimulation (a mild electrical treatment) improves balance and walking in people with spinal cord injuries. Participants will join one of three groups: one receives robotic training with real electrical stimulation, another with a sham version, and the last group uses only a treadmill. Eligible participants can already walk a bit on a treadmill, have a spinal cord injury between certain neck and back areas, and do not use leg braces that extend past the knee. Those who fit this description and are medically stable may consider joining to potentially improve mobility. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance mobility and quality of life.

What prior data suggests that this protocol is safe for spinal cord injury patients?

Research has shown that robotic training combined with spinal cord electrical stimulation is generally safe for individuals with spinal cord injuries. Studies indicate that this method, often paired with therapies like treadmill training, is well-tolerated, with most participants not experiencing serious side effects.

In one study, combining robotic training with spinal cord stimulation proved effective and safe, as participants demonstrated improvements in leg strength and walking ability after 20 sessions. Another study found that electrical stimulation with robotic training enhanced functions and was considered safe after multiple sessions.

For the group receiving robotic training without active electrical stimulation (sham stimulation), similar safety was observed. The robotic component of the treatment aids movement and has been shown to be safe for individuals with partial spinal cord injuries.

Overall, both the active and sham versions of the treatment have maintained good safety records in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord electrical stimulation for spinal cord injury because it offers a unique approach compared to traditional rehabilitation methods like physical therapy and medication. Unlike standard treatments, this method directly targets the spinal cord with electrical impulses, potentially enhancing nerve function and promoting recovery. The combination of robotic treadmill training with active spinal cord stimulation is particularly promising, as it could improve motor function more effectively by simulating natural walking patterns and boosting neural activity. This innovative technique might lead to quicker and more significant improvements, offering new hope for individuals with spinal cord injuries.

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

Research has shown that combining robotic training with electrical stimulation of the spinal cord can aid recovery from spinal cord injuries. In this trial, one group of participants will receive robotic treadmill training with active spinal cord electrical stimulation. Studies have found that this combination can strengthen leg muscles and improve walking. Another group will undergo robotic training with sham spinal cord stimulation, while a separate group will receive only conventional treadmill training. Patients receiving the active treatment often experience improved nerve function, as repeated training helps injured nerves recover. Many sessions are typically needed to see improvements, and additional sessions can lead to even better outcomes. Overall, this method shows promise in aiding recovery for people with spinal cord injuries. ^{2 5 6 7 8}

Who Is on the Research Team?

Ming Wu, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with spinal cord injuries between C4-T10 who can walk on a treadmill for over 20 minutes and more than 10 meters without or with knee-high orthotics. They must be medically stable and not have severe diseases, recent fractures, Botox treatments within six months, ongoing physical therapy, or metal implants in the spine.

Inclusion Criteria

Medically stable with medical clearance to participate

I can move my legs enough to walk.

I can walk on a treadmill for over 20 minutes, with breaks and support if needed.

Exclusion Criteria

I received a Botox injection in the last 6 months and am undergoing physical therapy.

I have had multiple fractures or injuries to my legs.

I have a metal implant in my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treadmill training with or without spinal cord stimulation, three times a week for 6 weeks

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for changes in balance and gait speed post-treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Training
• Spinal Cord Electrical Stimulation
• Treadmill

Trial Overview The study tests if pelvis perturbation training combined with electrical stimulation improves balance and walking in people with SCI. Participants are divided into three groups: one gets training plus real stimulation (tsDCS), another gets training plus fake stimulation (sham), and the last group only does treadmill exercises.

How Is the Trial Designed?

Group I: robotic training & stimulation Experimental Treatment 3 Interventions

Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.

Group II: robotic training & sham Active Control 2 Interventions

Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.

Group III: treadmill only Placebo Group 1 Intervention

Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39885542/

Transcutaneous spinal cord stimulation combined with ... 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 ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

4. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1252651/full

The effect of robot-assisted gait training for patients with ... Robot-assisted gait training has been shown to enhance neuroplasticity, whereby injured nerves gradually regain their functionality through repetitive training ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9611825/

The Outcomes of Robotic Rehabilitation Assisted Devices ... The study on 12 patients demonstrated that robot-assisted training has superior results in patients with incomplete injury and preserved function [67]. Most ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923010474

Robotic Rehabilitation and Spinal Cord Injury: a Narrative ... In this review, we discuss advances in robot-guided rehabilitation after SCI for the upper and lower extremities, as well as potential adjuncts to robotics.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03555838

Combined Robotic Training and tDCS in Chronic SCI The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and ...