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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

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 EksoGT™ for stroke recovery?

Research shows that powered robotic exoskeletons like EksoGT™ can help improve walking ability in stroke patients, especially those in the early stages of recovery. While results are similar to traditional therapy for chronic stroke patients, sub-acute patients may see additional benefits from using exoskeletons. ^{1 2 3 4 5}

Is robotic exoskeleton-assisted gait training safe for stroke recovery?

Clinical trials show that powered robotic exoskeletons, like the EksoNR, can be used safely for gait training in stroke patients. Studies indicate that this approach is well tolerated and can improve walking and functional status. ^{1 3 6 7 8}

How does the treatment EksoGT™ differ from other treatments for stroke recovery?

EksoGT™ is a robotic exoskeleton that provides intensive, repetitive walking practice, which can help stroke survivors relearn how to walk by promoting brain plasticity (the brain's ability to change and adapt). This approach is unique because it allows for active patient participation and can be more beneficial for sub-acute stroke patients compared to traditional therapy. ^{1 2 3 4 8}

Research Team

Karen J. Nolan, PhD

Principal Investigator

Kessler Foundation

Soha Saleh, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

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

Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. [2020]

4. United States 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. [2023]

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

Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study. [2023]

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

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. [2023]

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

Driving electromechanically assisted Gait Trainer for people with stroke. [2019]

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

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]