ExoNET Device for Stroke Survivors

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Bilateral paresis, Multiple strokes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. 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.

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 data supports the effectiveness of the ExoNET treatment for stroke survivors?

Research on similar devices, like powered robotic exoskeletons, shows they can help stroke survivors improve their walking ability by providing intensive gait training. These devices are especially beneficial for patients in the early stages of recovery, helping them relearn how to walk more effectively. ^{1 2 3 4 5}

Is the ExoNET device generally safe for human use?

The available research does not provide specific safety data for the ExoNET device or similar devices for stroke survivors, but it highlights the importance of monitoring medical devices for adverse events and recalls, which can sometimes lead to serious health consequences. ^{6 7 8 9 10}

How is the ExoNET treatment different from other stroke rehabilitation treatments?

The ExoNET treatment is unique because it likely involves a wearable device that assists stroke survivors in regaining movement, similar to other exoskeleton-based therapies. These devices often use advanced technologies like electromyography (EMG) to help control movements, providing a more interactive and personalized rehabilitation experience compared to traditional physical therapy. ^{1 11 12 13 14}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• ExoNET (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Shirley Ryan AbilityLab Chicago, IL

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Dr. Pablo Celnik

Shirley Ryan AbilityLab

Chief Executive Officer since 2023

MD from University of Buenos Aires Faculty of Medical Sciences

Dr. James Sliwa

Shirley Ryan AbilityLab

Chief Medical Officer since 2021

DO

Findings from Research

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]

References

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

Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. [2021]

3. United States 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. [2023]

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

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

5. Italy pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases. [2022]

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

Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

A UK medical devices regulator's perspective on registries. [2017]

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

Prevalence and nature of adverse medical device events in hospitalized children. [2021]

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

Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials. [2022]

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

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. [2019]

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

Development of a biomimetic hand exotendon device (BiomHED) for restoration of functional hand movement post-stroke. [2021]

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

An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. [2022]

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

Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. [2020]