Robotic Gait Training for Spinal Cord Injury

(DOOR SCI Trial)

Overseen By Faith Meza, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Moderate/severe TBI, Degenerative diagnoses, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different amounts of robotic gait training (RGT) can help people with spinal cord injuries improve their walking ability. Researchers aim to determine if adding transcranial magnetic stimulation (TMS), a type of brain stimulation, enhances the training's effectiveness. Participants will receive varying frequencies of RGT sessions or standard care without robotics. The trial suits individuals with incomplete spinal cord injuries who are in the early stages of recovery and receiving care at a specific rehabilitation center. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance rehabilitation techniques for spinal cord injuries.

Do I need to stop my current medications for the trial?

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 robotic gait training is safe for spinal cord injury patients?

Research shows that robotic gait training (RGT) is generally safe for people with spinal cord injuries. Studies have found that RGT can significantly improve daily activities, muscle strength, and walking abilities. A review of multiple studies found that this type of training can enhance the quality of life for those with spinal cord injuries, indicating it is well-tolerated.

Although the studies do not specifically focus on safety, they report no serious side effects. This suggests that RGT is relatively safe for most participants. For those considering joining a trial for robotic gait training, this research suggests a positive safety profile can be expected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic gait training for spinal cord injury because it offers a high-tech approach to rehabilitation. Unlike standard physical therapy that relies on manual techniques, robotic gait training uses advanced robotics to simulate walking patterns with precision. This technology can provide consistent, repetitive motion, potentially leading to improved motor recovery. Additionally, by offering different frequencies of training sessions, the treatment can be tailored to fit individual needs, optimizing recovery outcomes. Overall, robotic gait training represents a promising advancement in enhancing mobility for those with spinal cord injuries.

What evidence suggests that robotic gait training is effective for spinal cord injury?

This trial will compare different frequencies of robotic gait training (RGT) with usual care gait training for individuals with spinal cord injuries. Studies have shown that RGT can significantly aid people with spinal cord injuries by easing daily activities, strengthening muscles, and enhancing walking. Research also indicates that RGT improves walking ability and ease of movement, promoting a healthier lifestyle. Additionally, RGT improves balance and muscle coordination. These benefits suggest that RGT could be a promising option for enhancing mobility in those with spinal cord injuries. ^{1 2 4 5 6}

Who Is on the Research Team?

Chad Swank, PhD, PT, NCS

Principal Investigator

Baylor Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals with motor incomplete spinal cord injuries, in the acute or subacute recovery phase. Participants must be medically stable and receiving care at Baylor Scott & White Institute for Rehabilitation. They should fit within the Ekso robotic exoskeleton's size limits and manage bladder/bowel continence. Exclusions include severe TBI, degenerative conditions, cognitive impairments, pregnancy, or living over 90 miles from the institute.

Inclusion Criteria

I have an incomplete spinal cord injury that affects my movement.

You must fit within the size limits of the Ekso robotic exoskeleton.

I am receiving care at Baylor Scott & White Institute for Rehabilitation.

Exclusion Criteria

I have a condition that is getting progressively worse.

I have a moderate to severe brain injury.

You have a developmental disability, significant mental health diagnosis, or other thinking problems before the start of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Rehabilitation

Participants begin robotic gait training (RGT) during inpatient rehabilitation

6-12 weeks

Multiple sessions per week

Outpatient Rehabilitation

Continuation of RGT sessions in outpatient settings with varying frequency

6-12 weeks

2-4 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Periodic assessments at 1-month and 9-months post-SCI

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Gait Training
• Usual Care (UC) Gait Training

Trial Overview The DOOR SCI study is testing how different amounts of robotic gait training (RGT) combined with transcranial magnetic stimulation (TMS) affect functional outcomes and brain changes after a spinal cord injury. This happens during inpatient rehab and continues into early outpatient care.

How Is the Trial Designed?

Group I: Moderate Frequency Experimental Treatment 1 Intervention

Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks

Group II: Low Frequency Experimental Treatment 1 Intervention

Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks

Group III: High Frequency Experimental Treatment 1 Intervention

Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks

Group IV: Control Group Active Control 1 Intervention

Subjects will receive usual care gait training without robotic gait training

Robotic Gait Training is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Approved in United States as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Approved in Canada as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Approved in Switzerland as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Texas Woman's University

Collaborator

Trials

90

Recruited

5,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Texas Woman's University

Collaborator

Trials

1

Recruited

140+

Published Research Related to This Trial

In a study involving 12 patients with chronic spinal cord injury, both standard rehabilitation and robot-assisted gait training (RAGT) led to increased self-selected walking speed, indicating short-term efficacy in improving gait functions.

RAGT specifically contributed to a significant increase in step length, which was associated with improved hip flexor muscle function, highlighting its potential as a beneficial intervention in rehabilitation for SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study. Yoshikawa, K., Mutsuzaki, H., Koseki, K., et al.[2023]

In a study involving 15 spinal cord injury patients, overground robotic gait training (Ekso GT) required higher energy expenditure and cognitive effort compared to treadmill robotic training (Lokomat), indicating a more demanding rehabilitation process.

Despite the increased effort, both robotic systems were well-received by patients, with improvements in walking economy observed, suggesting that both methods can be effective in enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy cost and psychological impact of robotic-assisted gait training in people with spinal cord injury: effect of two different types of devices. Corbianco, S., Cavallini, G., Dini, M., et al.[2021]

A network meta-analysis of 12 studies involving 353 participants with spinal cord injury found that wearable exoskeleton-assisted walking (EAW) significantly improved walking distance and speed compared to Lokomat training.

While both Lokomat and EAW enhanced locomotor abilities, EAW showed a higher probability of improving walking speed, suggesting it may be a more effective option for enhancing locomotion in individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Efficacy of Lokomat and Wearable Exoskeleton-Assisted Gait Training in People With Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. Zhang, L., Lin, F., Sun, L., et al.[2022]

Robot-assisted gait training (RAGT) significantly improves walking-related outcomes, such as gait distance and leg strength, in patients with incomplete spinal cord injury, especially during the acute phase of recovery, compared to over-ground training (OGT).

In chronic spinal cord injury patients, RAGT also enhances walking speed and balance more effectively than no intervention, suggesting it is a valuable rehabilitation technique for restoring mobility and promoting a healthier lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review. Nam, KY., Kim, HJ., Kwon, BS., et al.[2020]

The Walkbot robotic-assisted gait training (RAGT) system significantly improved hip and knee movement and reduced stiffness in individuals with paraplegia or quadriplegia after 8 weeks of training, involving an average of 43 sessions.

This study provides the first clinical evidence that Walkbot RAGT can enhance functional mobility and daily activities in patients who had previously plateaued in their recovery, indicating its potential as a valuable rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Walkbot gait training on kinematics, kinetics, and clinical gait function in paraplegia and quadriplegia. Hwang, J., Shin, Y., Park, JH., et al.[2019]

End-effector robot-assisted gait training (RAGT) significantly improved balance and gait abilities in patients with spinal cord injury (SCI) compared to conventional therapy, as shown by better scores on the Berg Balance Scale and Walking Index for Spinal Cord Injury-II.

Both RAGT and conventional therapy led to improvements in various clinical measures of gait and mobility, but RAGT showed superior outcomes, indicating its potential as a more effective rehabilitation method for individuals with incomplete SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of end-effector robot-assisted gait training on gait ability, muscle strength, and balance in patients with spinal cord injury. Shin, JC., Jeon, HR., Kim, D., et al.[2023]

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]

A systematic review of 12 studies involving 5 to 130 participants with spinal cord injuries found that robotic assisted gait training (RAGT) did not significantly improve walking speed compared to conventional gait training.

While RAGT shows potential benefits for upright locomotion in spinal cord injury individuals, it should be used as a complementary therapy rather than a replacement for other rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of robot assisted gait training on temporal-spatial characteristics of people with spinal cord injuries: A systematic review. Hayes, SC., James Wilcox, CR., Forbes White, HS., et al.[2019]

Citations

1. 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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405650223000254

Review article Gait quality after robot therapy compared ... This systematic review compares the effectiveness of robot-assisted gait training (RAGT) with Lokomat® and OGT for individuals with spinal cord injury during ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0232-3

Robot-assisted gait training (Lokomat) improves walking ... RAGT treatment is a promising technique to restore functional walking and improve locomotor ability, which might enable SCI patients to maintain a healthy ...

4. 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 seems to be helpful for patients with spinal cord to improve TUG. It may not affect gait distance, gait speed, leg strength, 10 ...

5. mdpi.com mdpi.com/2306-5354/12/7/752

Lokomat-Assisted Robotic Rehabilitation in Spinal Cord ... Lokomat-based therapy has improved biomechanical symmetry, muscular coordination, and psychological and quality-of-life outcomes in individuals with partial ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05401734

Robot Assisted Gait Training in Persons With a Spinal Cord ... RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising.