Robotic Exoskeleton-Assisted Gait Training for Stroke Recovery

(RE-Assist Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kessler Foundation

Disqualifiers: Hypertension, Heart disease, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 30

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve walking after a stroke using a robotic exoskeleton called EksoGT™. The main goal is to determine if this high-tech approach can enhance independent walking by encouraging the brain to adapt and recover. Participants will either use the exoskeleton or undergo regular physical therapy for ten weeks, while a healthy group will undergo testing without therapy. This trial suits recent stroke survivors who can safely use the exoskeleton and have no major health issues affecting their ability to walk.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 the EksoGT™ is safe for stroke recovery?

Studies have shown that the EksoGT™, a robotic exoskeleton, is generally well-tolerated by stroke patients. One study found that 46 patients who recently had a stroke used this exoskeleton to help them walk, significantly improving their walking abilities. No major safety concerns were reported. Another research review highlighted the potential of these exoskeletons to assist with walking practice after a stroke. While some users might experience mild discomfort or tiredness, serious side effects are rare. As this trial is in the early stages, it primarily focuses on ensuring the treatment's safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the robotic exoskeleton-assisted gait training using the EksoGT™ because it offers a cutting-edge approach to stroke recovery. Unlike traditional gait training methods, which rely solely on manual physical therapy, the EksoGT™ uses a robotic exoskeleton to help patients relearn how to walk. This technology provides consistent and precise support, potentially leading to more effective rehabilitation. Additionally, the robotic exoskeleton can offer real-time feedback and adjust to the patient's progress, providing a personalized rehabilitation experience that standard physical therapy cannot. This innovation holds promise for improving mobility outcomes much faster and more efficiently than the standard of care.

What evidence suggests that the EksoGT™ is effective for stroke recovery?

Research shows that robotic exoskeletons, like the EksoGT™, can help people walk again after a stroke. In this trial, participants in the Stroke RE group will use the EksoGT™ for robotic exoskeleton gait training. Studies have found that these devices improve how stroke survivors walk and their overall ability to function. Although some research found no major difference compared to regular therapy, many other studies report positive results. The EksoGT™ supports and guides the legs, helping retrain the brain and muscles to work together again. This method aims to enhance recovery by encouraging neuroplasticity, the brain's ability to adapt and change after an injury. ^{2 3 5 6 7}

Who Is on the Research Team?

Karen J. Nolan, PhD

Principal Investigator

Kessler Foundation

Soha Saleh, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 21-80, within 4 weeks post-stroke, who can understand instructions and use an exoskeleton device. They must fit certain height (below 60" or above 76") and weight (above 220 lbs) requirements, have unilateral hemiparesis, normal limb range of motion for walking with assistive devices, and no severe cognitive issues. Excluded are those with recent heart issues, uncontrolled conditions affecting movement or full weight bearing ability, skin problems preventing device wear, exercise intolerance due to pre-existing conditions like severe cardiac disease or metal implants not MRI-compatible.

Inclusion Criteria

I can understand and follow study instructions and provide feedback.

My other limb has no injuries or diseases.

I had a stroke less than 4 weeks ago.

Exclusion Criteria

I have not been hospitalized for a heart attack, surgery, or acute failure in the last 3 months.

If you have serious memory or thinking problems, or have trouble controlling your bladder, you may not be able to start training with a RE.

I have a condition like Parkinson's or MS that affects my movement or walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the stroke RE group undergo robotic exoskeleton gait training 3 days a week for 10 weeks, while the stroke SOC group receives standard of care gait training.

10 weeks

30 visits (in-person)

Follow-up

Participants are monitored for changes in brain activity and walking ability after the treatment phase.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EksoGT™

Trial Overview

The study tests the EksoGT™ robotic exoskeleton's effectiveness in aiding gait rehabilitation post-stroke compared to standard care without intervention. It aims to leverage neuroplasticity through massed practice using the exoskeleton for potential improvements in independent walking abilities.

How Is the Trial Designed?

Group I: Stroke RE Experimental Treatment 1 Intervention

After discharge from the acute rehabilitation facility, participants in the stroke RE group will participate 3 days a week for 10 weeks in robotic exoskeleton gait training provided by a trained, licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.

Group II: Healthy Control Experimental Treatment 1 Intervention

Participants in the healthy control group will not participate in any gait training. Healthy control participants will only be asked to complete 3 testing sessions.

Group III: Stroke SOC Active Control 1 Intervention

After discharge from the acute rehabilitation facility, participants in the stroke SOC group will participate 3 days a week for 10 weeks in standard of care gait training provided by a licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, S., et al.[2020]

Intensity modulated robotic exoskeleton gait training significantly improved walking speed and functional mobility in stroke survivors over a 10-week period, with participants training at 75-85% of their maximum heart rates during 30 sessions.

These preliminary results suggest that using robotic exoskeletons for gait training can enhance motor recovery and functional ambulation in post-stroke rehabilitation, although further research is needed to fully understand the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Exoskeleton Gait Training Post Stroke. Nolan, KJ., Ames, GR., Dandola, CM., et al.[2023]

Robotic-assisted gait training (RAGT) using the EksoNR exoskeleton significantly improved gait and functional status in 19 stroke patients over a 4-week rehabilitation program, with notable enhancements in walking ability and mobility.

The study showed statistically significant improvements in various functional categories, including a substantial increase in the number of steps taken and walking time, indicating that RAGT is both effective and well-tolerated for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. Wiśniowska-Szurlej, A., Wołoszyn, N., Brożonowicz, J., et al.[2023]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

Exoskeleton-assisted gait training using the Healbot G significantly increased cortical activity in stroke patients compared to traditional treadmill training, indicating enhanced brain engagement during rehabilitation.

Patients in the Healbot G group showed significant improvements in walking ability, balance, and lower limb strength, demonstrating the efficacy of exoskeleton training in enhancing recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial. Yoo, M., Chun, MH., Hong, GR., et al.[2023]

Citations

1.

frontiersin.org

frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1391322/full

Robotic exoskeleton-assisted walking rehabilitation for ...

This study aimed to conduct a bibliometric analysis of the literature on exoskeleton robot assisted walking rehabilitation for stroke patients.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9980569/

Efficacy of robotic exoskeleton for gait rehabilitation in patients ...

The aim of the present study was to assess the efficacy of RAGT for gait recovery in subacute stroke survivors. DESIGN. Systematic review with meta-analysis.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10355131/

Enhanced Rehabilitation Outcomes of Robotic-Assisted ...

This study supports previous findings, demonstrating that RAGT using the EksoNR lower extremity exoskeleton improves gait and functional status in stroke ...

4.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-016-0162-5

Powered robotic exoskeletons in post-stroke rehabilitation of gait

Two of the four controlled trials showed no greater improvement in any walking outcomes compared to a control group in chronic stroke. In ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590109524001009

Efficacy of Robot-assisted Training on Upper Limb Motor ...

However, some clinical trials, found that exoskeleton robot-assisted therapy (Exo-RAT) has a positive effect on the improvement of upper limb motor function in ...

6.

withpower.com

withpower.com/trial/phase-gait-disorders-neurologic-2020-27286

Robotic Exoskeleton-Assisted Gait Training for Stroke ...

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6988257/

Exoskeleton for post-stroke recovery of ambulation (ExStRA)

Outcome data will be collected at baseline, post-intervention, and at 6 months. The qualitative component will explore the experience and ...