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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Real-time Neuromuscular Control of Exoskeletons for stroke patients?

Research shows that exoskeletons can help stroke patients improve their walking and arm movements by providing support and assistance. Studies have found that these devices can safely aid in movement without causing stress or pain, and they can help therapists identify and address muscle weaknesses and coordination issues. ^{1 2 3 4 5}

Is exoskeleton-assisted movement safe for stroke rehabilitation?

Clinical trials show that powered robotic exoskeletons can be used safely for gait training in stroke patients, with no adverse effects reported in studies involving both lower-limb and upper-limb exoskeletons. ^{1 2 4 6 7}

How does the Real-time Neuromuscular Control of Exoskeletons treatment differ from other stroke treatments?

This treatment is unique because it uses real-time neuromuscular control to assist movement, relying on the patient's own muscle signals to guide the exoskeleton. This approach enhances the patient's active participation in rehabilitation, unlike traditional therapies that may not integrate real-time feedback from muscle activity. ^{4 5 8 9 10}

What is the purpose of this trial?

The purpose of this study is to develop a real-time controller for exoskeletons using neural information embedded in human musculature. This controller will consist of an online interface that anticipates human movement based on high-density electromyography (HD-EMG) recordings, and then translates it into functional assistance. This study will be carried out in both healthy participants and participants post-stroke. The researchers will develop an online algorithm (decoder) in currently existing exoskeletons that can extract hundreds of motor unit (MU) spiking activity out of HD-EMG recordings. The MU spiking activity is a train of action potentials coded by its timing of occurrence that gives access to a representative part of the neural code of human movement. The researchers will also develop a command encoder that can anticipate human intent (multi-joint position and force commands) from MU spiking activity to translate the neural information to movement. The researchers will integrate the decoder with the command encoder to showcase the real-time control of multiple joint lower-limb exoskeletons.

Research Team

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. 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]

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

Exploring the Capabilities of Harmony for Upper-Limb Stroke Therapy. [2020]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Mechanics and energetics of post-stroke walking aided by a powered ankle exoskeleton with speed-adaptive myoelectric control. [2020]

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

Delayed Muscle Activity in Stroke Survivors with Upper-Limb Hemiparesis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Effects of an exoskeleton-assisted gait training on post-stroke lower-limb muscle coordination. [2021]

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

The eWrist - A wearable wrist exoskeleton with sEMG-based force control for stroke rehabilitation. [2018]

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

Simulation on the Effect of Gait Variability, Delays, and Inertia with Respect to Wearer Energy Savings with Exoskeleton Assistance. [2020]

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

Proportional EMG control for upper-limb powered exoskeletons. [2020]