Robotic Gait Training for Spinal Cord Injury

(DOOR SCI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Chad Swank, PhD, PT, NCS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baylor Research Institute

Disqualifiers: Moderate/severe TBI, Degenerative diagnoses, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses robotic devices and magnetic stimulation to help people with partial spinal cord injuries recover better. It focuses on rehabilitation to maximize recovery by practicing walking and stimulating the brain. Robotic devices and magnetic stimulation are increasingly used in neurorehabilitation to facilitate repetitive motor training and enhance recovery in individuals with 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 data supports the effectiveness of the treatment Robotic Gait Training for Spinal Cord Injury?

Research shows that robotic-assisted gait training (RAGT) can significantly improve walking distance, leg strength, and mobility in people with spinal cord injuries, especially when started soon after the injury. It has been found to be more effective than conventional overground training in enhancing walking ability and independence.

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Is robotic gait training safe for humans?

Research on robotic gait training, including devices like Lokomat and wearable exoskeletons, suggests it is generally safe for people with spinal cord injuries, although specific safety data is not detailed in the studies.

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How is Robotic Gait Training different from other treatments for spinal cord injury?

Robotic Gait Training (RAGT) is unique because it uses advanced robotic systems to assist with walking, providing precise and consistent movement patterns that can help improve walking abilities in people with spinal cord injuries. Unlike traditional therapies, RAGT can be delivered through stationary systems like Lokomat or wearable exoskeletons, offering flexibility in rehabilitation settings.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baylor Scott & White Institute for Rehabilitation Dallas, TX

Who Is Running the Clinical Trial?

Baylor Research Institute Lead Sponsor

Texas Woman's University Collaborator

United States Department of Defense Collaborator

Texas Woman's University Collaborator

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Walkbot gait training on kinematics, kinetics, and clinical gait function in paraplegia and quadriplegia. [2019] The robotic-assisted gait training (RAGT) system has gained recognition as an innovative, effective paradigm to improve functional ambulation and activities of daily living in spinal cord injury and stroke. However, the effects of the Walkbot robotic-assisted gait training system with a specialized hip-knee-ankle actuator have never been examined in the paraplegia and quadriplegia population.

2. England pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review. [2020] Robot-assisted gait training (RAGT) after spinal cord injury (SCI) induces several different neurophysiological mechanisms to restore walking ability, including the activation of central pattern generators, task-specific stepping practice and massed exercise. However, there is no clear evidence for the optimal timing and efficacy of RAGT in people with SCI. The aim of our study was to assess the effects of RAGT on improvement in walking-related functional outcomes in patients with incomplete SCI compared with other rehabilitation modalities according to time elapsed since injury. This review included 10 trials involving 502 participants to meta-analysis. The acute RAGT groups showed significantly greater improvements in gait distance, leg strength, and functional level of mobility and independence than the over-ground training (OGT) groups. The pooled mean difference was 45.05 m (95% CI 13.81 to 76.29, P = 0.005, I2 = 0%; two trials, 122 participants), 2.54 (LEMS, 95% CI 0.11 to 4.96, P = 0.04, I2 = 0%; three trials, 211 participants) and 0.5 (WISCI-II and FIM-L, 95% CI 0.02 to 0.98, P = 0.04, I2 = 67%; three trials, 211 participants), respectively. In the chronic RAGT group, significantly greater improvements in speed (pooled mean difference = 0.07 m/s, 95% CI 0.01 to 0.12, P = 0.01, I2 = 0%; three trials, 124 participants) and balance measured by TUG (pooled mean difference = 9.25, 95% CI 2.76 to 15.73, P = 0.005, I2 = 74%; three trials, 120 participants) were observed than in the group with no intervention. Thus, RAGT improves mobility-related outcomes to a greater degree than conventional OGT for patients with incomplete SCI, particularly during the acute stage. RAGT treatment is a promising technique to restore functional walking and improve locomotor ability, which might enable SCI patients to maintain a healthy lifestyle and increase their level of physical activity.

3. Switzerland 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. [2022] Lokomat and wearable exoskeleton-assisted walking (EAW) have not been directly compared previously. To conduct a network meta-analysis of randomized and non-randomized controlled trials to assess locomotor abilities achieved with two different types of robotic-assisted gait training (RAGT) program in persons with spinal cord injury (SCI).

4. Italy 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. [2021] In the last years, there has been an intense technological development of robotic devices for gait rehabilitation in spinal cord injury (SCI) patients. The aim of the present study was to evaluate energy cost and psychological impact during a rehabilitation program with two different types of robotic rehabilitation systems (stationary system on a treadmill, Lokomat, and overground walking system, Ekso GT).

5. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. [2022] To assess the quality of current evidence as to the effectiveness of robot-assisted gait training in spinal cord injured patients, focusing on walking ability and performance.

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

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study. [2023] To explore changes in gait functions for patients with chronic spinal cord injury (SCI) before and after standard rehabilitation and rehabilitation with a wearable hip device, explore the utility of robot-assisted gait training (RAGT), and evaluate the safety and dose of RAGT.

7. England 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. [2019] Robotic assisted gait training (RAGT) technology can be used as a rehabilitation tool or as an assistive device for spinal cord injured (SCI) individuals. Its impact on upright stepping characteristics of SCI individuals using treadmill or overground robotic exoskeleton systems has yet to be established.

8. Netherlands 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. [2023] There is no randomized controlled study about the effects of end-effector robot-assisted gait training (RAGT) in patients with spinal cord injury (SCI).