Robotic Leg Movements for Spinal Cord Injury

Overseen By Dobrivoje Stokic, MD, DSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Methodist Rehabilitation Center

Disqualifiers: Uncontrolled diabetes, Severe contractures, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different speeds of robotic leg movements can aid people with spinal cord injuries in managing dizziness and lightheadedness when standing. The researchers aim to determine if faster leg movements reduce symptoms of orthostatic hypotension (a drop in blood pressure when standing) more effectively than slower movements. Participants should have experienced these symptoms during therapy or have been identified by their therapist as having them. This study may suit individuals who have had a spinal cord injury for 12 weeks or less and have experienced drops in blood pressure when moving to an upright position. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance management strategies for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this robotic leg movement technique is safe for spinal cord injury patients?

Research has shown that using robotic devices to assist people with spinal cord injuries in moving their legs is generally safe. For example, one study with 50 patients found this type of training both feasible and safe, with no serious side effects. Participants felt comfortable and confident using these devices. Another study with 12 patients also demonstrated positive results, particularly for those who retained some leg function after their injury. Overall, these findings suggest that robotic leg movements are well-tolerated and safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Robotic Leg Movements for spinal cord injury because this technique introduces a novel method of rehabilitation. Unlike traditional therapies that rely on manual physical exercises, this approach uses a robotic tilt-stepper to provide progressive elevation and controlled stepping motions at varying speeds. This innovative method aims to enhance neural recovery and muscle coordination by mimicking natural walking patterns, potentially offering a more efficient and targeted way to improve mobility in individuals with spinal cord injuries.

What evidence suggests that robotic leg movements are effective for spinal cord injury?

Research has shown that robotic leg movements, which participants in this trial will experience, can help people with spinal cord injuries improve daily activities and build muscle strength. Studies have found that robotic-assisted walking training greatly enhances walking abilities without causing major health problems. This training uses robotic devices to assist with walking exercises, which can be especially beneficial for those with severe spinal cord injuries. Although some reports suggest that robotic exoskeletons might not always lead to significant improvements, overall evidence supports the potential benefits of robotic leg movements. These exercises might also help prevent issues like a sudden drop in blood pressure when standing by adjusting the speed of movement. ^{1 4 6 7 8}

Who Is on the Research Team?

Dobrivoje Stokic, MD, DSc

Principal Investigator

Methodist Rehabilitation Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 16-70 with recent spinal cord injuries (SCI) who experience low blood pressure when standing, weighing less than 297 lbs with leg lengths of 29" - 39". It's not for those with weight-bearing issues, skin lesions where the device fits, uncontrolled diabetes, severe joint contractures in lower limbs, or increased pain/spasticity during leg movements.

Inclusion Criteria

You have experienced noticeable signs of low blood pressure during or outside of therapy sessions, or your primary therapist has noted a drop in blood pressure during therapy sessions.

Your spinal cord injury occurred within the last 12 weeks.

You weigh less than 297 pounds and have a leg length between 29 and 39 inches.

Exclusion Criteria

You have weight-bearing restrictions as noted in your medical records or by your main therapist (for spinal cord injury).

You have skin sores that make it difficult to use the tilt-table or robot cuffs.

You have uncontrolled diabetes with nerve-related issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training Session

Participants undergo a one-time training session with the ErigoPro to assess the impact of robotic leg movement speed on orthostatic hypotension

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the training session

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Leg Movements

Trial Overview The study tests if different speeds of robotic leg movements using ErigoPro can help manage orthostatic hypotension—low blood pressure upon standing—in people with subacute SCI. It compares faster cadence to slower cadence to see which better prevents or reduces these drops in blood pressure.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Progressive elevation (0 degrees, 25 degrees, 50 degrees, 75 degrees; x2 minutes in each position) while on robotic tilt-stepper at the cadence of 0, 40, and 80 steps/minute.

Who Is Running the Clinical Trial?

Methodist Rehabilitation Center

Lead Sponsor

Trials

7

Recruited

170+

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]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

A review of studies on robot-assisted gait training for spinal cord injury patients found that while some improvements in body functions were noted, the evidence is insufficient to conclude that this method is more effective than traditional locomotor training due to small sample sizes and methodological issues.

The analysis included 6 trials with 43 patients, primarily using devices like the Lokomat, but highlighted the need for better-designed randomized controlled trials to establish the efficacy of robot-assisted training in improving walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. Swinnen, E., Duerinck, S., Baeyens, JP., et al.[2022]

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

Citations

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

The Outcomes of Robotic Rehabilitation Assisted Devices ... Patients with severe SCI impairment can conduct efficient gait exercise without any particular health consequences due to robotic-assisted gait training (RAGT) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11217760/

Robot-Assisted Gait Training in Individuals With Spinal Cord ... This meta-analysis revealed that RAGT significantly improved activities of daily living, muscular strength, and walking abilities.

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01649-1

Comparative efficacy of robotic exoskeleton and conventional ... The analysis indicated that there were no significant improvements observed in SCI patients who underwent robotic exoskeleton gait training ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525001119

Therapeutic Effects of Noninvasive Technology Modalities ... Outcomes were evaluated in four studies for motor score, seven for muscle performance, and seven for walking ability. Most interventions ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1126755/full

The effectiveness of robotic-assisted upper limb ... Robot-assisted training of arm and hand movement shows functional improvements for incomplete cervical spinal cord injury. Am J Phys Med Rehabil. (2017) 96 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10274525/

Results of 50 patients - PMC - PubMed Central HAL® locomotion training is feasible and safe in the rehabilitation of acute SCI patients. The HAL® exoskeleton enables the patient to perform ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.689751/full

Outcomes of a Multicenter Safety and Efficacy Study of the ... There were no serious adverse events. All participants reported moderate to high levels of comfort and confidence using the device. All patients ...

8. 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.