Robotic Exoskeletons for Stroke Recovery

(RERC Trial)

Overseen By Kathleen Goworek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Hypertension, Coronary artery disease, others

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

Compensation: Varies

Number of Visits: 9

Duration: 3-4 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different robotic exoskeletons can aid in recovering walking ability after a stroke. The main goal is to determine which type of robotic exoskeleton works best for each individual, enabling doctors to make more informed rehabilitation choices. The trial includes two groups: one using robotic exoskeletons and another following standard care practices, both participating in gait training sessions. It suits stroke survivors who experienced a stroke 3 to 8 months ago and can use a walking aid like a cane or walker. Participants must fit into the exoskeleton and have no conditions that would prevent safe walking. As an unphased trial, this study allows participants to contribute to innovative research that could improve rehabilitation options for future stroke survivors.

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 study staff or your doctor.

What prior data suggests that these robotic exoskeletons are safe for stroke recovery?

Earlier studies have shown that robotic exoskeletons help stroke patients walk faster, longer, and with better balance. Research shows these devices can also strengthen the legs and improve overall movement. Additionally, evidence indicates that patients experienced no negative side effects during sessions with the robotic exoskeletons. Sessions were paused only for patients with a specific type of stroke called ischemic infarcts. Overall, these findings suggest that robotic exoskeletons are generally safe and well-tolerated for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic exoskeletons for stroke recovery because they offer a cutting-edge way to aid rehabilitation. Unlike standard physical therapy, which relies on traditional exercises, these exoskeletons provide powered assistance to help patients regain mobility by mimicking natural walking movements. This technology allows for precise, repetitive gait training, which could potentially accelerate recovery and improve outcomes for stroke survivors. Additionally, the robotic support enables consistent therapy sessions, potentially reducing the physical strain on both patients and therapists.

What evidence suggests that robotic exoskeletons are effective for stroke recovery?

This trial will compare robotic exoskeletons with standard gait training for stroke recovery. Research has shown that robotic exoskeletons can improve walking in stroke patients. One study found that these devices enhanced balance and walking patterns. Another study demonstrated that robotic assistance improved movement, particularly in the arms. Additionally, robot-assisted walking devices can reduce muscle effort in the legs, potentially easing movement. Overall, these findings suggest that robotic exoskeletons can aid stroke recovery by enhancing walking and movement. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children and adults who have difficulty walking due to muscle weakness on one side of their body, often after a stroke. Specific criteria will be used to determine if they're suitable for the study.

Inclusion Criteria

Medical clearance by the Medical Director

Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation (e.g. can follow directions)

I had a stroke between 3 to 8 months ago.

Exclusion Criteria

I do not have seizures, muscle stiffness, or joint issues that affect my walking.

I can walk and bear weight without any medical issues.

I don't have skin problems that would stop me from wearing a medical device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gait training using robotic exoskeletons or standard of care for 3-4 weeks, 2-3 times a week, totaling 9 sessions

3-4 weeks

9 visits (in-person)

Follow-up

Participants are monitored for changes in gait, balance, and quality of life metrics after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Exoskeleton

Trial Overview

The study is testing different robotic exoskeletons designed to help patients walk better. It aims to find out which exoskeleton works best based on individual needs during rehabilitation.

How Is the Trial Designed?

Group I: Stroke RE Experimental Treatment 1 Intervention

Participants in the stroke RE group will participate 3-4 weeks, 2-3 times a week for a total of 9 robotic exoskeleton gait training sessions provided by a trained, licensed physical therapist.

Group II: Stroke SOC Active Control 1 Intervention

Participants in the stroke SOC group will participate 3-4 weeks, 2-3 times a week for a total of 9 standard of care gait training sessions provided by a trained, licensed physical therapist.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

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]

In a study of 38 post-stroke patients, those who received robotic-exoskeleton-assisted rehabilitation showed significantly greater improvements in knee flexion torque, walking distance, and quality of life compared to those receiving standard rehabilitation alone.

Robotic training was identified as the strongest predictor of improvement in walking speed and overall health-related quality of life, highlighting its effectiveness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait Rehabilitation and Predictive Factors of Significant Improvements in Stroke Patients: A Randomized Controlled Trial. Lee, YH., Ko, LW., Hsu, CY., et al.[2023]

In a study involving 44 participants with acute stroke, those using robotic exoskeletons (RE) for gait training walked twice the distance compared to those receiving standard care, indicating enhanced rehabilitation potential.

The RE group also showed a greater improvement in functional independence, as measured by the Functional Independence Measure (FIM), suggesting that increased dosing of gait training through RE may lead to better motor function recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. Nolan, KJ., Karunakaran, KK., Chervin, K., 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]

The H2 robotic exoskeleton was evaluated in a small study with 3 hemiparetic stroke patients over 4 weeks, demonstrating safety and ease of use without any adverse events reported.

This novel device allows for intensive overground gait training, showing promise for enhancing rehabilitation efforts and engaging patients actively in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. Bortole, M., Venkatakrishnan, A., Zhu, F., et al.[2022]

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