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Behavioural Intervention

ExoNET Device for Stroke Survivors

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

Severe to moderate upper extremity impairment (ARAT score 0-30)

Cortical stroke with hemiparesis, tactile sensation

Must not have

Hemispatial neglect or visual field cut that prevent visual feedback

Diffuse/multiple lesion sites or multiple stroke events

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment phases (week 1, week 2 and week 3)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a robotic device called ExoNET that helps stroke patients improve their forearm movement. The study will look at whether the device is safe, effective, and easy to use.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the ExoNET is a non-invasive mechanical device, side effects may include discomfort at contact points or skin irritation from wearing the device. More serious risks could involve muscle strain or joint pain due to incorrect use.

Eligibility Criteria

Inclusion Criteria

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

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

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

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I am between 40 and 70 years old.

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I can move my elbow and wrist against gravity.

Exclusion Criteria

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

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I have trouble seeing on one side, which affects my vision.

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I have had multiple strokes or have many affected areas in my brain.

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I have weakness in both sides of my body.

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I have other neurological conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment phases (week 1, week 2 and week 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment phases (week 1, week 2 and week 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment phases (week 1, week 2 and week 3) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Action Research Arm Test (ARAT)

Secondary study objectives

Box and Blocks

Upper extremity portion of the Fugl-Meyer (FMUE)

Other study objectives

Electromyography using Delsys

Joint Kinematics using Microsoft Kinect

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 - Sham, Assistance, Anti-AssistanceExperimental Treatment3 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-AssistanceExperimental Treatment3 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.

0 / 8Eligibility criteria met