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

35 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Robotic Leg Movements for Spinal Cord Injury?

Research shows that robotic leg movements can help people with spinal cord injuries relearn how to walk by allowing natural movements and providing assistance only when needed. This approach helps the spinal cord reorganize and improve coordination, increasing the chances of successful rehabilitation. ^{1 2 3 4 5}

Is the use of robotic leg movements for spinal cord injury generally safe?

Robotic leg movements, like powered exoskeletons, have been studied for safety in people with spinal cord injuries. While some studies report no serious adverse events and high user satisfaction, there are risks of fractures and other injuries, such as skin and musculoskeletal issues, which need careful management and training. ^{6 7 8 9 10}

How does the Robotic Leg Movements treatment for spinal cord injury differ from other treatments?

Robotic Leg Movements treatment is unique because it uses robotic devices to assist with natural gait movements and force control, allowing for 'assist-as-needed' training. This approach encourages the generation of stepping rather than fully assisting movements, which can lead to better locomotor recovery by promoting neuroplasticity and motor learning. ^{1 2 11 12 13}

What is the purpose of this trial?

This study seeks to evaluate whether the speed (cadence) of lower extremity robotic movement has an impact on orthostatic hypotension and upright tolerance when training with the ErigoPro robotic tilt-stepper. It is hypothesized more frequent short-lasting leg movements (faster cadence) reduces the occurrence/severity of orthostatic hypotension better than less frequent longer-lasting leg movements (slower cadence).

Research Team

Dobrivoje Stokic, MD, DSc

Principal Investigator

Methodist Rehabilitation Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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

Robotic training and spinal cord plasticity. [2021]

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

Robotic gait training: toward more natural movements and optimal training algorithms. [2020]

3. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. [2022]

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

Robot-Assisted Training for People With Spinal Cord Injury: A Meta-Analysis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Paralysis recovery in humans and model systems. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of a Multicenter Safety and Efficacy Study of the SuitX Phoenix Powered Exoskeleton for Ambulation by Patients With Spinal Cord Injury. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

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

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

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

Tools for understanding and optimizing robotic gait training. [2019]

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

Robotic assistance that encourages the generation of stepping rather than fully assisting movements is best for learning to step in spinally contused rats. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

MotionTherapy@Home - First results of a clinical study with a novel robotic device for automated locomotion therapy at home. [2011]