ExoNET for Stroke

Overseen By Courtney Celian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Under 18, Bilateral paresis, Spasticity, others

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

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

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 device supports the arm to ease movement, aiming to improve therapy outcomes. Participants will use the ExoNET either with or without gravity support to determine which method is more effective. The trial seeks individuals who had a stroke at least 8 months ago, experience arm weakness on one side, and can move their shoulder and elbow to some extent. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the affected arm within the last 4 months, you cannot participate.

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

Research has shown that exoskeleton devices like ExoNET are generally safe for stroke patients. One study tested a similar device on six stroke patients and found no serious side effects or safety issues. Another study examined various exoskeletons used for stroke rehabilitation and found them effective without causing harm. These findings suggest that exoskeleton devices, including ExoNET, are safe and well-tolerated for aiding stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for stroke, which often involve medication and physical therapy, ExoNET offers a unique approach by using a device that compensates for gravity. This innovative mechanism assists stroke patients in regaining movement more naturally by reducing the physical effort required to move their limbs. Researchers are excited about ExoNET because it might enhance rehabilitation outcomes by enabling more effective and sustained practice of motor skills, potentially speeding up recovery and improving overall mobility.

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

Research has shown that the ExoNET device could aid recovery after a stroke. In this trial, participants in the experimental group will use the ExoNET device, which provides gravity compensation to assist in lifting the arm, helping stroke patients regain strength and movement. One study found that ExoNET's support system is safe and practical, aiding patients in relearning movement. Early results indicate that ExoNET can effectively address movement problems in stroke survivors, suggesting that the device could improve arm function in these individuals. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had a stroke more than 8 months ago.

You have a moderate impairment, with a Fugl-Meyer score between 15 and 50.

I have weakness on one side of my body.

Exclusion Criteria

I have moderate muscle stiffness.

I have shoulder pain or stiffness in my arm joint.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluations including Fugl-Meyer, Wolf Motor Function Test, Action Research Arm Test, and Box and Blocks

1 week

1 visit (in-person)

Treatment

Participants perform reaching, arm elevation, and flexion task exercises wearing the ExoNET device

2 weeks

2 visits (in-person)

Post Evaluation

Post evaluations including Fugl-Meyer, Wolf Motor Function Test, Action Research Arm Test, and Box and Blocks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ExoNET

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental Group: Gravity Compensation Experimental Treatment 1 Intervention

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

Group II: Control Group: No Gravity Compensation Placebo Group 1 Intervention

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

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6988257/

Exoskeleton for post-stroke recovery of ambulation (ExStRA)

This study will be the first mixed-methods study examining the adoptability of exoskeleton-based rehabilitation for individuals with stroke.

2.

researchgate.net

researchgate.net/publication/382596129_Evaluation_of_a_passive_wearable_arm_ExoNET

(PDF) Evaluation of a passive wearable arm ExoNET

Conclusions Anti-gravity therapy with the ExoNET is a safe and feasible treatment for post-stroke rehabilitation. The device provided anti ...

3.

withpower.com

withpower.com/trial/phase-stroke-9-2023-fe77c

BCI-Controlled Robotic Exoskeleton for Stroke

This trial tests a remote therapy that helps stroke patients move their hands using brain signals to control a robotic device. It targets patients with ...

4.

researchgate.net

researchgate.net/publication/393626610_Structural_Optimization_of_a_Passive_ExoNET_for_Forearm_Supination

Structural Optimization of a Passive ExoNET for Forearm ...

Initial results demonstrate that the diagnostic device effectively identifies supination torque deficits in stroke survivors, while the ...

5.

withpower.com

withpower.com/trial/startle-adjuvant-rehabilitation-therapy-for-stroke-4fc5a

Startle Adjuvant Rehabilitation Therapy for Stroke

Research shows that starting rehabilitation early after a stroke can improve recovery, and this is a key part of effective stroke care. Although specific data ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12551560/

Usability of Myosuit exosuit and effects of device-mediated ...

The aim of this study is to assess the usability of the Myosuit within a chronic stroke survivors' rehabilitation program and to explore its ...

7.

medicalsciencepulse.com

medicalsciencepulse.com/article/549895/en

Clinical outcomes in post-stroke rehabilitation using upper ...

The extracted data included the following information about upper-limb exoskeletons: their effectiveness in post-stroke motor rehabilitation and ...

8.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01421-x

Safety & efficacy of a robotic hip exoskeleton on outpatient ...

Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03980457

Effects of Exoskeleton-Assisted Gait Training on Functional ...

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients ...

10.

researchgate.net

researchgate.net/publication/372503070_Safety_and_usability_of_the_MAK_exoskeleton_in_patients_with_stroke

Safety and usability of the MAK exoskeleton in patients with ...

Results: Six participants with stroke were recruited. The device was shown to be safe since no serious adverse events were reported neither by ...