Exoskeleton-Assisted Movement for Stroke

Overseen By Jose Pons, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Neurological medications, Recreational drugs

Disqualifiers: Neurological disorders, Heart disease, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve movement using exoskeletons, wearable devices that support mobility. Researchers are developing a system called Real-time Neuromuscular Control of Exoskeletons, which reads muscle signals to predict and assist movement in real-time. The trial involves two groups: healthy participants and those who have had a stroke and can walk independently. Individuals who experienced a stroke more than six months ago and can walk on flat ground may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance mobility for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that influence brain function, you may not be eligible to participate.

What prior data suggests that this exoskeleton-assisted movement is safe for stroke patients?

Research has shown that using exoskeletons for stroke recovery is generally safe and well-tolerated. Studies with similar devices have demonstrated positive results with few side effects. For instance, one study found that robotic exoskeletons helped stroke patients improve their movement without major problems. Another study on walking rehabilitation reported that users, including those with neurological conditions, felt safe using the device.

The exoskeleton technology in this trial builds on these earlier studies. While specific data for this exact device is not yet available, it resembles those previously tested. As the trial is in an early stage, researchers are still gathering detailed safety information. However, testing on both healthy individuals and stroke survivors has shown confidence in its safety.

Overall, existing research supports exoskeletons as a safe option for helping regain movement after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how real-time neuromuscular control of exoskeletons can aid movement in stroke patients. Unlike traditional rehab methods, which often rely on physical therapy or medications to improve mobility, this approach uses advanced technology to directly assist and enhance muscle activity during tasks like walking or squatting. The unique feature here is the real-time interaction between the patient's neuromuscular signals and the exoskeleton, potentially offering a more responsive and personalized rehabilitation experience. This could lead to improved motor function and faster recovery times for stroke survivors.

What evidence suggests that this exoskeleton-assisted movement is effective for stroke?

Research has shown that exoskeletons can help stroke survivors improve their movement. In this trial, participants will use real-time neuromuscular control of exoskeletons to assist with movement. One study found that a special hip-wearable exoskeleton positively affected walking. This suggests that exoskeletons might aid rehabilitation by supporting better walking patterns. The technology uses sensors to detect muscle signals, helping the exoskeleton move in sync with the person. Early results suggest this method could make walking smoother and less tiring, enhancing movement and aiding recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with normal movement in their limbs, no brain/skull lesions, correctable hearing and vision. It includes stroke survivors who had a unilateral, supratentorial stroke over 6 months ago without other neurological disorders.

Inclusion Criteria

I have never had a brain or skull lesion.

I had a stroke in the upper part of my brain more than 6 months ago.

My hearing and vision are normal or corrected to normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experiment A

Muscle activity data collection via HD-EMG from healthy and post-stroke participants during single-joint and locomotor tasks

4-6 weeks

Multiple sessions for data collection

Experiment B

Calibration and real-time assistance with exoskeleton for healthy and post-stroke participants, including multiple sessions to evaluate decoder stability

10 weeks

Up to 10 sessions for post-stroke participants

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Real-time Neuromuscular Control of Exoskeletons

Trial Overview The study tests a new controller for exoskeletons that uses muscle signals to predict movements. Participants will perform various muscle contractions and activities while wearing an exoskeleton that's guided by this technology.

How Is the Trial Designed?

Group I: Healthy Participants Experimental Treatment 5 Interventions

The investigators will look at muscle activity of healthy participants from eight lower limb muscles during functional tasks (e.g. single-joint movement, walking, squatting, cycling).

Group II: Clinical Participants Experimental Treatment 5 Interventions

The investigators will look at muscle activity of participants post-stroke from eight lower limb muscles during functional tasks (e.g. single-joint movement, walking, squatting, cycling).

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Using a simple EMG-proportional control for an elbow exoskeleton allows users to adapt quickly and effectively, reducing their effort while maintaining control over their movements.

This study suggests that high-accuracy torque estimates may not be necessary for effective movement assistance in powered exoskeletons, highlighting the potential for simpler control methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proportional EMG control for upper-limb powered exoskeletons. Lenzi, T., De Rossi, SM., Vitiello, N., et al.[2020]

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]

The novel ankle exoskeleton controller effectively increased assistive torque based on walking speed and muscle activity, leading to significant improvements in paretic ankle joint power and total limb power across various walking speeds in six stroke participants.

Despite the benefits in joint power, there were no metabolic advantages observed with exoskeleton assistance, suggesting that improving limb posture may be necessary to enhance forward propulsion during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanics and energetics of post-stroke walking aided by a powered ankle exoskeleton with speed-adaptive myoelectric control. McCain, EM., Dick, TJM., Giest, TN., 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 study involved 10 stroke subjects and 11 able-bodied individuals to assess the impact of a powered exoskeleton on gait and neuromuscular coordination, revealing that the exoskeleton did not significantly alter the coordination complexity of the stroke subjects' muscle activation after training.

However, using the exoskeleton during walking did change the muscle synergy patterns in stroke subjects, moving their activation profiles closer to those of able-bodied individuals, suggesting potential benefits for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an exoskeleton-assisted gait training on post-stroke lower-limb muscle coordination. Zhu, F., Kern, M., Fowkes, E., et al.[2021]

Delays as small as 10 milliseconds between a wearer's desired ankle movement and the exoskeleton's response can significantly reduce the effectiveness of the assistance provided, highlighting the importance of minimizing these delays in design.

High variability in a wearer's gait also leads to decreased assistance from the exoskeleton, suggesting that training to improve gait consistency could enhance the overall effectiveness of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation on the Effect of Gait Variability, Delays, and Inertia with Respect to Wearer Energy Savings with Exoskeleton Assistance. Fang, S., Kinney, AL., Reissman, ME., et al.[2020]

The Harmony exoskeleton was tested with five stroke survivors over seven hours of therapy, allowing them to perform 1130 motions without any reported adverse effects, indicating its safety for clinical use.

The device not only assists in rehabilitation but also helps therapists assess motor function and develop personalized therapy plans, showing promise for improving upper-limb coordination and function in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Capabilities of Harmony for Upper-Limb Stroke Therapy. Oliveira, AC., Rose, CG., Warburton, K., et al.[2020]

The eWrist is a novel wearable exoskeleton designed to assist stroke patients with wrist extension training, which is crucial for daily activities, by providing support based on the user's muscle activation.

Preliminary results indicate that using surface electromyography (sEMG) to control the device allows for tailored assistance, enhancing the training experience and potentially promoting recovery through cortical reorganization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The eWrist - A wearable wrist exoskeleton with sEMG-based force control for stroke rehabilitation. Lambelet, C., Lyu, M., Woolley, D., et al.[2018]

Stroke survivors with upper-limb hemiparesis experience significantly delayed muscle contraction and relaxation, with initiation of hand movements taking about three times longer on the affected side compared to the non-affected side, which can hinder the use of myoelectric exoskeletons.

Understanding these EMG differences is crucial for improving the design of assistive devices and rehabilitation strategies, as real-time feedback on muscle activity could enhance recovery monitoring and therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Muscle Activity in Stroke Survivors with Upper-Limb Hemiparesis. Lopez, DR., Thomson, CJ., Mino, FR., 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]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/49942?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Real-time Neuromuscular Control of Exoskeletons - Clinica... The researchers will record muscle activity in healthy participants and participants post-stroke from up to eight lower limb muscles (soleus ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482354/

A novel real-time assistive hip-wearable exoskeleton robot ... This study aimed to explore the effect of this robot on lower extremity rehabilitation in subacute stroke patients, focusing on gait function, ...

3. medicalsciencepulse.com medicalsciencepulse.com/article/549895/en

Clinical outcomes in post-stroke rehabilitation using upper ... We describe the design of these exoskeletons and report clinical outcomes based on FMA-UE scores following therapy. Conclusions: Our analysis ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265130/

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

5. rehab.jmir.org rehab.jmir.org/2019/2/e12010/

Exoskeletons With Virtual Reality, Augmented Reality, and ... It aims to assess the effectiveness of exoskeleton robotics in conjunction with any of the three technologies (VR, AR, or gamification) in ...

6. clinicaltrial.be clinicaltrial.be/en/details/49942?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Real-time Neuromuscular Control of Exoskeletons - Clinica... The researchers will record muscle activity in healthy participants and participants post-stroke from up to eight lower limb muscles (soleus ...

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00750-x

Exoskeleton use in post-stroke gait rehabilitation: a qualitative ... This study provides an interpretive understanding of end-users perspectives, persons with stroke and neurological physiotherapists, following a single-use ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06736171

Post Stroke Ambulation Recovery Using Robotic ... Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes. Change from Baseline at 4 weeks.