Robotic Exoskeleton-Assisted Gait Training for Stroke Recovery
(RE-Assist Trial)
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.12345
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.23567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for changes in brain activity and walking ability after the treatment phase.
What Are the Treatments Tested in This Trial?
Interventions
- EksoGT™
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor