Robotic Gait Training for Stroke

(ERA Stroke Trial)

Overseen By Faith Meza, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Concurrent neurological diagnoses, profound cognitive impairment, pregnancy

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: 1

Duration: 2 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether robotic gait training (RGT) or usual care (UC) better aids walking recovery after a stroke. Participants who recently experienced a stroke and are in early recovery will receive either RGT, which involves walking practice with a robotic device, or UC, which involves traditional physical therapy. The research aims to determine which method more effectively improves walking. Ideal participants are those recovering from a stroke, are medically stable, and are undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation with the goal of walking again. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance stroke recovery therapies.

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 stroke patients?

Research has shown that robotic walking training is generally safe for stroke patients. A review of several studies found that adding robotic-assisted walking training to regular physical therapy can double the chances of walking recovery, suggesting the treatment is well-tolerated. Another study highlighted that this type of training is promising for helping patients regain function after a stroke.

Most studies indicate that robotic walking training is as effective as traditional physical therapy in improving balance. While these studies focus on its effectiveness, they also suggest that the treatment does not cause significant harm. No major reports of negative effects or side effects have been noted, indicating it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robotic Gait Training is unique because it uses robotic technology to assist stroke patients in walking, which is different from standard physical therapy that relies solely on human guidance. This approach allows for precise control over movement patterns and intensity, potentially leading to more efficient and effective rehabilitation. Researchers are excited about this treatment because the robotic assistance can provide consistent, repeatable movements that may accelerate recovery and improve walking ability more than traditional methods.

What evidence suggests that robotic gait training is effective for stroke recovery?

This trial will compare Robotic Gait Training (RGT) with usual care gait training for stroke recovery. Studies have shown that RGT can significantly aid stroke recovery. Research indicates that RGT improves walking, balance, and stamina in stroke survivors. One study found that robotic training enhanced lower body function more than traditional walking exercises. Another study suggested that robotic devices like the Lokomat® assist with balance recovery, offering benefits similar to regular physical therapy. Overall, strong evidence supports using RGT to help stroke patients regain mobility. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for stroke patients aged 18-85 in the early recovery phase who have the potential to regain walking ability. Participants must be medically stable, able to fit into a robotic exoskeleton, and managing continence. It excludes those with severe cognitive issues, pregnancy, or other neurological conditions like TBI.

Inclusion Criteria

Acute/subacute phase of recovery

My gender, race, or ethnicity does not limit my participation.

I have had a stroke.

Exclusion Criteria

I have significant difficulties with thinking or memory.

Pregnancy

I have a brain-related condition like TBI or a brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either robotic gait training or usual care gait training for 90 minutes each week during their inpatient rehabilitation stay

2 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at discharge, 1 month, and 3 months post-discharge

3 months

Assessments at discharge, 1 month, and 3 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Gait Training

Trial Overview The study compares two types of gait training: Robotic Gait Training (RGT) using an exoskeleton and Usual Care (UC) methods during inpatient rehab at BSWIR. The goal is to see which method better aids patients recovering from different types of strokes.

How Is the Trial Designed?

Group I: Robotic Gait Training Experimental Treatment 1 Intervention

Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.

Group II: Usual Care Gait Training Active Control 1 Intervention

Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.

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+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

Participants in a 6-week robotic-assisted gait training (RAGT) intervention using the HAL exoskeleton reported that the training was demanding but beneficial, highlighting the importance of support and feedback from therapists for motivation.

The study suggests that while RAGT can inspire confidence and improvement in walking ability after stroke, further development of exoskeletons is needed to enhance comfort and promote active participation in various environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' experiences of intensive robotic-assisted gait training post-stroke - "a push forward or feeling pushed around?" Nedergård, H., Sandlund, M., Häger, CK., et al.[2023]

In a study of 24 stroke patients undergoing robotic-assisted gait training, both exoskeleton (Lokomat) and end-effector (G-EO) devices showed improvements in walking function, with G-EO patients demonstrating enhancements across all functional tests, while Lokomat patients improved in fewer areas.

Despite the positive outcomes, the study's small sample size, retrospective design, and significant drop-out rate (5 out of 24 participants) suggest that further research is necessary to confirm these findings and explore differences in efficacy, safety, and cost-effectiveness between the two robotic training devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-Assisted Gait Training (RAGT) in Stroke Rehabilitation: A Pilot Study. Neves, MVM., Furlan, L., Fregni, F., et al.[2023]

In a study of 63 participants with subacute stroke, conventional gait training resulted in significantly greater improvements in walking speed and distance compared to robotic-assisted training with the Lokomat, with these benefits lasting for at least 3 months after training.

While both training methods showed similar outcomes in secondary measures like balance and mobility, conventional training led to a two-fold greater improvement in walking cadence, suggesting its effectiveness in enhancing overall gait performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Hidler, J., Nichols, D., Pelliccio, M., et al.[2022]

Robotic-assisted gait training (RAGT) significantly improved the ability to walk independently in patients after subacute stroke, as indicated by higher functional ambulatory capacity scores compared to regular physiotherapy alone, based on a study of 67 patients over 6 weeks.

Patients receiving RAGT also showed better neurological status improvements, suggesting that this treatment may enhance recovery outcomes in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. Schwartz, I., Sajin, A., Fisher, I., et al.[2022]

A systematic review of 13 studies involving 412 stroke patients found that Robotic-Assisted Gait Training (RAGT) showed slight improvements in certain gait parameters, such as stride length and step length on the affected side, compared to non-robotic training.

However, the overall evidence for the effectiveness of RAGT in improving gait biomechanics post-stroke is of very low certainty, highlighting the need for more rigorous clinical trials to better understand its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of robotic-assisted gait training on objective biomechanical measures of gait in persons post-stroke: a systematic review and meta-analysis. Nedergård, H., Arumugam, A., Sandlund, M., et al.[2023]

In a study involving 40 nonambulatory patients with subacute stroke, the novel hybrid robot-assisted gait training (RAGT) system showed significant improvements in lower-extremity motor function and balance compared to conventional rehabilitation alone, particularly in the Fugl-Meyer Assessment scores.

While the RAGT group demonstrated better outcomes in specific assessments, the overall evidence for its clinical effectiveness compared to standard rehabilitation remains inconclusive, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid robot-assisted gait training for motor function in subacute stroke: a single-blind randomized controlled trial. Lin, YN., Huang, SW., Kuan, YC., et al.[2023]

In a study involving 20 adults with chronic stroke, both robotic-assisted treadmill training using the Lokomat(®) and over-ground gait training (OGT) showed improvements in lower extremity motor function and physical independence over 8 weeks, but no significant differences were found between the two methods.

The Lokomat(®) may be particularly beneficial for lower-functioning patients as it allows for more intensive training with less physical strain on therapists, although there is a noted risk of skin breakdown associated with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial. Kelley, CP., Childress, J., Boake, C., et al.[2016]

Robot-assisted gait training (RAGT) has been shown to improve balance in stroke patients, with significant effect sizes observed across various balance assessment tests, including the Berg Balance Scale and Timed Up and Go test.

Despite the improvements in balance, the review found no significant differences in balance outcomes between RAGT and other gait rehabilitation methods, indicating that while RAGT is beneficial, its superiority over traditional methods remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Swinnen, E., Beckwée, D., Meeusen, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12250684/

Effectiveness of Robot-Assisted Gait Training in Stroke ... Background/Objectives: Robotic-assisted gait training (RAGT) is a promising adjunct to conventional rehabilitation for stroke survivors.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000022

Robotic-Assisted Gait Training (RAGT) in Stroke ... To compare the effects of 2 types of robotic-assisted gait training (RAGT) devices that have been used in stroke rehabilitation.

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01463-1

Efficacy of robot-assisted gait training on lower extremity ... This study provides evidence that RAGT can enhance lower extremity function, balance function, walking ability, and endurance levels compared to CGT.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.661815/full

The Effect of Robotic Assisted Gait Training With Lokomat ... Most studies have shown beneficial effects of Lokomat ® on balance recovery for stroke survivors, at least comparable to conventional physical therapy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07040215?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DTaiwan))))&rank=2

Effects on Subacute Stroke With Robotic Assistive Gait ... The goal of this randomized controlled trial is to learn about the effects of Robotic Assisted Gait Training (RAGT) combined with traditional physical therapy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11639496/

Robot-assisted gait training in stroke - PMC Robot-assisted gait training may be a promising method leading to functional recovery in patients with stroke.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8289887/

The Effect of Robotic Assisted Gait Training With Lokomat® on ... Most studies have shown beneficial effects of Lokomat® on balance recovery for stroke survivors, at least comparable to conventional physical therapy.

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01243-3

Feasibility and outcomes of supplemental gait training by ... To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04910217

Robot-Assisted Gait Therapy in the Subacute Phase of First ... Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group ...