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

Trial Summary

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 data supports the effectiveness of the treatment Robotic Exoskeleton for stroke recovery?

Research shows that robotic exoskeletons can help improve walking ability in stroke patients, especially those in the early stages of recovery. Some studies found that these devices are as effective as traditional therapy, with potential added benefits for patients who recently had a stroke. ^{1 2 3 4 5}

Is the use of robotic exoskeletons generally safe for humans?

Robotic exoskeletons have been used safely in clinical trials for stroke rehabilitation, with regulatory approvals in place for devices like ReWalk™, Indego™, and Ekso™. However, there are reports of adverse events such as skin and musculoskeletal injuries, and changes in blood pressure, indicating a need for better risk management and reporting to ensure safety. ^{1 6 7 8 9}

How is the Robotic Exoskeleton treatment different from other stroke recovery treatments?

The Robotic Exoskeleton treatment is unique because it uses advanced technology to assist with movement and rehabilitation after a stroke. It integrates a brain-machine interface (BMI) that can potentially decode brain signals to control the exoskeleton, offering a novel way to aid recovery by directly linking brain activity with physical movement. ^{3 10 11 12 13}

What is the purpose of this trial?

The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

References

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

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

2. Switzerland 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. [2022]

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. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Predictors of Functional Outcome in a Cohort of Hispanic Patients Using Exoskeleton Rehabilitation for Cerebrovascular Accidents and Traumatic Brain Injury. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. [2020]

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

An integrated neuro-robotic interface for stroke rehabilitation using the NASA X1 powered lower limb exoskeleton. [2020]

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

NEUROExos: A powered elbow orthosis for post-stroke early neurorehabilitation. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of robot-assisted training on upper limb functional recovery during the rehabilitation of poststroke patients. [2018]

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

Robotics, stem cells, and brain-computer interfaces in rehabilitation and recovery from stroke: updates and advances. [2023]