ExoNET Device for Stroke Survivors

Overseen By Courtney Celian, MSOT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Bilateral paresis, Multiple strokes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called ExoNET, designed to assist stroke survivors with arm movement. The researchers aim to determine if this exoskeletal device, which uses springs to aid arm rotation, is safe and effective. Participants will try various settings on the device to identify the most effective configuration. It suits individuals who experienced a single stroke at least eight months ago and have moderate to severe arm movement difficulties but can still move their elbow and wrist with support. As an unphased trial, this study allows participants to contribute to innovative research that could improve rehabilitation options for stroke survivors.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants who have had Botox injections in the affected arm within the last 4 months.

What prior data suggests that the ExoNET device is safe for stroke survivors?

Earlier studies have shown that ExoNET is a safe choice for aiding recovery after a stroke. Research indicates that the device, which assists in moving the forearm, is easy for users to handle. Participants in these studies reported no serious side effects. ExoNET supports the arm without motors or electricity, potentially enhancing its safety. Overall, current evidence suggests that ExoNET is both safe and effective for stroke survivors during recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ExoNET device for stroke survivors because it offers a unique approach to rehabilitation. Unlike traditional physical therapy, which relies on repetitive manual exercises, ExoNET uses advanced settings to provide assistance, anti-assistance, and sham interventions, adapting to the user's progress. This device has the potential to enhance motor recovery by dynamically adjusting support, making the rehabilitation process more personalized and potentially more effective. With its innovative use of cutting-edge technology, ExoNET could significantly improve outcomes for stroke survivors by promoting faster and more efficient recovery.

What evidence suggests that the ExoNET device is effective for stroke survivors?

Studies have shown that robotic therapy can greatly improve arm movement in stroke patients. This trial evaluates the ExoNET device, which assists with arm movements and is being assessed for safety and practicality in stroke recovery. The device uses springs to aid in turning the forearm, a task often challenging after a stroke. Participants in Group 1 will experience the interventions in the order of assistance, sham (slack springs), then anti-assistance, while those in Group 2 will receive them in the order of sham, assistance, then anti-assistance. Clinical results suggest that these robotic devices can lead to better long-term recovery of arm function. Overall, the ExoNET shows promise in helping stroke survivors regain arm movement. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult stroke survivors who need help with forearm rotation (supination). Participants must be able to give consent and follow study procedures. Specific medical conditions or treatments that might interfere with the trial are reasons for exclusion.

Inclusion Criteria

Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct

I have severe to moderate difficulty using my arms and hands.

I had a stroke that affected my movement and touch on one side.

Exclusion Criteria

Severe sensory deficits indicated by the Two-Point Discrimination Test

Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands

Meet any of the contraindications to Delsys Trigno Sensors: Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators; Irritated skin or open wounds; Silver allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET. Interventions include sham, assistance, and anti-assistance settings.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using outcome measures like ARAT, FMUE, and Box and Blocks.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ExoNET

Trial Overview The study tests an exoskeletal device called ExoNET, designed to assist forearm supination. There are three variations: one actually helps with movement, another provides resistance against it, and a third does nothing (sham). The goal is to see if it's safe and works as intended.

How Is the Trial Designed?

Group I: Group 2 - Sham, Assistance, Anti-Assistance Experimental Treatment 3 Interventions

Group 2 receives all three interventions in the order of sham (slack springs), then assistance, then anti-assistance. Each intervention corresponds to different settings on the device.

Group II: Group 1 - Assistance, Sham, Anti-Assistance Experimental Treatment 3 Interventions

Group 1 receives all three interventions in the order of assistance, then sham (slack springs), then anti-assistance. Each intervention corresponds to different settings on the device.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

In a study of 298 patients with moderate stroke and 284 with severe stroke across 5 rehabilitation facilities, occupational therapists and assistants provided the majority of therapy hours, with therapists focusing on advanced activities and assistants handling more basic tasks.

The use of therapy extenders varies by therapy type and patient severity, suggesting that the effectiveness of stroke rehabilitation may depend on how therapy is structured and delivered, highlighting the need for further research on their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. Hsieh, CH., Putman, K., Nichols, D., et al.[2019]

The novel EMG-driven exoneuromusculoskeleton significantly improved upper limb performance in stroke patients, enhancing joint extension and voluntary motor function during self-help training, as shown in a pilot trial with 15 participants after 20 sessions (p < 0.05).

The system effectively combined neuromuscular electrical stimulation and mechanical assistance, leading to reduced muscle spasticity and improved muscular coordination, demonstrating its potential for upper limb rehabilitation post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. Nam, C., Rong, W., Li, W., et al.[2022]

Between 2006 and 2010, there was a dramatic increase in medical device recalls in the UK, with 2124 field safety notices issued, indicating a growing concern for patient safety.

Many of the recalled devices, particularly those related to cardiovascular (25%) and musculoskeletal (33%) systems, were assessed to have a reasonable probability of causing serious health consequences or death, highlighting the need for better transparency and data access regarding device safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. Heneghan, C., Thompson, M., Billingsley, M., et al.[2021]

In a study of over 4 million admissions across 44 children's hospitals, 3.3% of patients experienced adverse medical device events (AMDEs), highlighting a significant safety concern in pediatric care.

Most AMDEs were associated with vascular access and nervous system devices, particularly affecting children with complex chronic conditions, indicating a need for targeted research to improve device safety in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and nature of adverse medical device events in hospitalized children. Brady, PW., Varadarajan, K., Peterson, LE., et al.[2021]

In a pilot study involving eight chronic stroke patients who completed 18 sessions with the Hand Exoskeleton Rehabilitation Robot, significant improvements were observed in hand function, including range of motion and grip strength, indicating the robot's potential efficacy in rehabilitation.

A subgroup of six patients with lower muscle tone showed even greater gains in hand function, suggesting that the intervention may be particularly beneficial for individuals with specific characteristics, although further research is needed to optimize treatment for those with higher levels of impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Godfrey, SB., Holley, RJ., Lum, PS.[2016]

The Biomimetic Hand Exoskeleton Device (BiomHED) effectively assists stroke survivors in producing complex hand movements, showing a significant increase in the kinematic workspace of the index finger by 63%-1014%.

Stroke survivors using the BiomHED demonstrated improved kinematics during a tip-pinch task, with a notable reduction in fingertip-thumb tip distance, indicating its potential for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a biomimetic hand exotendon device (BiomHED) for restoration of functional hand movement post-stroke. Lee, SW., Landers, KA., Park, HS.[2021]

Registries play a crucial role in post-market surveillance of implantable medical devices, helping manufacturers meet safety obligations and providing regulators with essential data for monitoring device performance.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) emphasizes that effective registries should have specific attributes to enhance their contribution to patient safety and medical device regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A UK medical devices regulator's perspective on registries. Wilkinson, J., Crosbie, A.[2017]

A comprehensive analysis of adverse events (AEs) from 5775 patients in acute ischemic stroke trials identified 132 expected AEs that accounted for 82.7% of reported events, primarily occurring within 10 days post-stroke.

Patient characteristics such as age, sex, baseline stroke severity, and multimorbidity status can modestly predict the incidence of AEs, helping to stratify patients by their risk for poststroke complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials. Hesse, K., Fulton, RL., Abdul-Rahim, AH., et al.[2022]

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 externally actuated glove for stroke survivors is designed to assist with finger extension, enabling users to practice hand therapy tasks at home, which is crucial for rehabilitation.

The device can be controlled through voice recognition, electromyography, or manual input, providing flexibility and safety with position and force feedback, and initial tests indicate it performs well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Ochoa, J., Dev Narasimhan, YJ., Kamper, DG.[2020]

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 Gait Enhancing and Motivating System-Hip (GEMS-H) significantly improved cortical activation patterns in chronic stroke patients during treadmill walking, promoting more symmetrical activation in the brain's sensorimotor cortex compared to walking without assistance.

Using GEMS-H resulted in reduced oxygenated hemoglobin levels in the late phase of walking, suggesting that it helps streamline gait by facilitating rhythmic hip movements, which may enhance overall gait efficiency and coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. Lee, SH., Lee, HJ., Shim, Y., et al.[2021]

The AVANCER trial demonstrated that a personalized intervention combining a brain-computer interface, exoskeleton, and functional electrical stimulation led to a significant improvement in upper-limb function for the first patient, as measured by a 4-point increase in the Fugl-Meyer assessment score from 6 to 11 points.

Neuroimaging and electrophysiological assessments indicated that this intervention not only improved motor function but also resulted in structural and functional changes in the brain, suggesting a potential mechanism for recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel personalized treatment strategy for patients with chronic stroke with severe upper-extremity impairment: The first patient of the AVANCER trial. Bigoni, C., Beanato, E., Harquel, S., et al.[2023]

A review of FDA databases revealed 120 unique adverse event reports related to Clinical Information Systems (CIS) from over 1.4 million total reports, highlighting issues like missing data and system downtime.

The findings suggest that while the number of reported adverse events is relatively low, there is a need for increased awareness and communication among manufacturers and users to improve the safety and effectiveness of CIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases. Myers, RB., Jones, SL., Sittig, DF.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40537460/

A Wearable Anti-Gravity Supplement to Therapy Does Not ... ConclusionsAnti-gravity therapy with the ExoNET is a safe and feasible treatment for post-stroke rehabilitation. The device provided anti ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524001009

Efficacy of Robot-assisted Training on Upper Limb Motor ... A clinical study also found better long-term improvement in upper limb functional recovery in patients with stroke after a 6-month follow-up evaluation of RAT.

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

Clinical outcomes in post-stroke rehabilitation using upper ... These results demonstrate the effectiveness of robotic therapy in improving upper limb motor function even in the early phase of post-stroke ...

4. 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 ...

5. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1391322/full

Robotic exoskeleton-assisted walking rehabilitation for ... This study aimed to conduct a bibliometric analysis of the literature on exoskeleton robot assisted walking rehabilitation for stroke patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05180812

NCT05180812 | Safety and Feasibility of ExoNET The purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity ...

7. trial.medpath.com trial.medpath.com/clinical-trial/117932610219efef/nct06655636-stroke-survivors-exoskeletal-forearm-supination

Safety and Feasibility of an ExoNET for Supination Assistance ... Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.

8. withpower.com withpower.com/trial/phase-stroke-1-2022-17eb4

ExoNET for Stroke · Info for Participants It aims to see if it's safe and practical for people recovering from a stroke to use this device as part of their rehabilitation. How Is the Trial Designed ...

9. frontiersin.org frontiersin.org/journals/robotics-and-ai/articles/10.3389/frobt.2024.1387177/full

Evaluation of a passive wearable arm ExoNET In this study, we investigated the safety and feasibility of gravity compensating ExoNETs on 10 healthy, unimpaired individuals across a series of tasks.