What side effects are associated with this type of intervention?

Common treatments for upper-extremity movement retraining post-stroke, such as robotic-assisted therapy and gravity compensation devices, generally have mild side effects. These can include muscle soreness, fatigue, and temporary discomfort at the site of attachment. In some cases, patients may experience skin irritation or pressure sores from prolonged use of the device. More broadly, stroke rehabilitation therapies can sometimes lead to overuse injuries if not properly monitored. It is important for patients to work closely with their healthcare providers to manage these side effects and adjust treatment protocols as needed.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke rehabilitation, particularly focusing on improving motor function in the upper extremities. One notable approval is for robotic-assisted therapy devices, such as the InMotion ARM, which aids in repetitive motion exercises to enhance arm and hand function. Additionally, the FDA has cleared various exoskeleton devices like the EksoGT, designed to assist with gait training and mobility. These technologies, similar to the ExoNET trial's focus on gravity compensation for upper-extremity movement retraining, aim to facilitate recovery by providing mechanical support and enhancing the effectiveness of physical therapy.

What other types of research exist?

Promising alternatives to ExoNET for upper-extremity movement retraining in stroke patients include: 1) Robotic-assisted therapy devices, which provide repetitive, high-intensity, and task-specific training. 2) Virtual reality (VR) and augmented reality (AR) systems, which offer immersive environments for engaging and motivating rehabilitation exercises. 3) Functional electrical stimulation (FES), which uses electrical currents to activate muscles and improve motor function. 4) Brain-computer interface (BCI) technology, which enables direct communication between the brain and external devices to facilitate motor recovery.

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Passive Robotic Device

ExoNET for Stroke

N/A

Waitlist Available

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hemiparesis

Be older than 18 years old

Must not have

Spasticity (Modified Ashworth Scale of 2)

Shoulder pain and/or articular rigidity on the upper limb joint

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

Summary

This trial is testing a wearable device called ExoNET that helps support the arm's weight. It is aimed at chronic post-stroke patients who have trouble moving their arms. By making it easier to lift and move the arm, the device helps patients practice movements, which can improve their strength and flexibility.

Who is the study for?

This trial is for adults who have had a stroke at least 8 months ago and now experience moderate arm weakness (hemiparesis). They should be able to move their shoulder and elbow somewhat but can't join if they have pain or stiffness in the joints, severe muscle tightness, recent Botox treatments in the arm, or problems with understanding that would affect participation.

What is being tested?

The study is testing ExoNET, a passive robotic device designed to help support the arm during therapy exercises. 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.

What are the potential side effects?

Since ExoNET is non-invasive and supports movement without motors or electricity, side effects are expected to be minimal. However, participants may experience discomfort due to new movements or adjustments made by the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weakness on one side of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate muscle stiffness.

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I have shoulder pain or stiffness in my arm joint.

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I am under 18 years old.

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I have weakness in both sides of my body.

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I do not have speech, thinking, or mood problems that would affect my participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

This trial's timeline: 3 weeks for screening, Varies for treatment, and tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper arm

Secondary study objectives

Box and Blocks

Fugl-Meyer

Wolf Motor Function Test

Other study objectives

Electromyography using Delsys

Kinect

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental Group: Gravity CompensationExperimental Treatment1 Intervention

The participants will be wearing the ExoNet device tuned to gravity support.

Group II: Control Group: No Gravity CompensationPlacebo Group1 Intervention

The participants will be wearing the ExoNet device, but it will not be tuned to gravity support.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke rehabilitation, particularly for upper limb impairments, include electrical stimulation, myoelectric bracing, and robotic-assisted therapy. Electrical stimulation helps activate muscles and improve motor function by delivering small electrical impulses to the affected muscles. Myoelectric bracing uses sensors to detect muscle activity and assist movement, enhancing strength and coordination. Robotic-assisted therapy, such as the ExoNET device, provides gravity compensation to support and retrain upper-extremity movements. These treatments are crucial for stroke patients as they promote neuroplasticity, improve motor recovery, and enhance the ability to perform daily activities, ultimately leading to better functional outcomes and quality of life.

Time to reconcile research findings and clinical practice on upper limb neurorehabilitation.Efficacy of myoelectric bracing in moderately impaired stroke survivors: A randomized, controlled trial.ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'.