What is the mechanism of action of this treatment?

The most common treatments for stroke, particularly those focusing on motor recovery and neuroplasticity, include physical therapy, occupational therapy, and device-assisted practice of activities of daily living (ADL). These treatments work by promoting neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for stroke patients as it helps in the recovery of motor functions and improves the ability to perform daily activities. Device-assisted ADL practice, in particular, facilitates motor recovery by providing repetitive, task-specific training that mimics normal movement patterns, thereby enhancing the brain's adaptive capabilities and improving functional outcomes.

What side effects are associated with this type of intervention?

Device-assisted practice of activities of daily living (ADL) for stroke rehabilitation aims to improve upper extremity motor recovery and neuroplasticity. Common side effects of such physical rehabilitation treatments are generally minimal but can include muscle soreness, fatigue, and, in rare cases, overuse injuries. These interventions are typically well-tolerated and considered safe, with the primary goal of enhancing functional recovery and independence in stroke survivors.

What prior FDA approvals exist?

FDA-approved treatments for stroke primarily focus on acute management and secondary prevention, including thrombolytics like alteplase (tPA) and anticoagulants. For motor recovery and neuroplasticity, rehabilitation therapies such as physical and occupational therapy are standard. While specific device-assisted ADL practices are still under investigation, other FDA-approved devices like robotic exoskeletons and neuromodulation devices have shown promise in aiding motor recovery post-stroke.

What other types of research exist?

Promising, novel alternatives to Device-Assisted ADL Practice for stroke patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells and improve motor function; 2) Virtual Reality (VR) Therapy, which provides immersive environments for motor skill practice and cognitive engagement; 3) Robotics-Assisted Therapy, which uses robotic devices to assist and enhance repetitive movement training; and 4) Stem Cell Therapy, which aims to repair damaged brain tissue and promote neuroplasticity. These treatments have shown potential in clinical studies and are expected to be more widely available in 2024.

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Device-assisted Practice

Device-Assisted ADL Practice for Stroke Recovery

N/A

Recruiting

Led By Jun Yao, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Intact skin on the hemiparetic arm

Discharged from all forms of physical rehabilitation

Must not have

Any brainstem and/or cerebellar lesion

Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week).

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates the use of a special device called ReIn-Hand to help stroke survivors practice everyday tasks. The device assists with arm and hand movements, making it easier for participants to perform these tasks. The goal is to improve the functional use of their affected arm and hand.

Who is the study for?

This trial is for individuals aged 21-80 who have had a moderate to severe stroke, resulting in significant arm weakness but with some ability to move. They must be able to sit for an hour, have a certain level of cognitive function (MoCA score >=23), and not be receiving other physical rehabilitation. Exclusions include recent seizures, severe sensory impairment in the arm, prior injections affecting muscle control, other neurological disorders or serious medical conditions.

What is being tested?

The study tests whether using a device called ReIn-Hand alongside robot assistance can help improve the use of arms/hands during daily activities after suffering from a stroke. It measures changes in motor skills and brain adaptability post-intervention.

What are the potential side effects?

Potential side effects are not explicitly listed; however, participants may experience discomfort or fatigue due to repetitive movements during therapy sessions with the ReIn-Hand device and robot-assisted exercises.

Eligibility Criteria

Inclusion Criteria

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

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My skin is healthy on the arm affected by my stroke.

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I have completed all my physical rehabilitation.

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I can open my hand at least 4 cm wide with help from a device and therapist.

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I understand and can agree to the study's procedures and risks.

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I have weakness on one side of my body, affecting my arm but can still move it a little.

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My cognitive function score is 23 or higher.

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I am between 21 and 80 years old.

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I can lift my arm and straighten my elbow somewhat against gravity.

Exclusion Criteria

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

Select...

I have a tumor in my brainstem or cerebellum.

Select...

I experience significant pain in my arms or back, rating it 5 or more out of 10.

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I have severe stiffness in my elbow, wrist, and fingers.

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I cannot lift my arm sideways or upwards to a right angle.

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I can attend sessions 3 times a week for 8 weeks and all evaluations.

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I have a history of a neurological disorder, but not stroke.

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I had arm or hand movement problems before my stroke.

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I have weakness or numbness in the limb not affected by my condition.

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I do not have severe health issues like heart problems or uncontrolled high blood pressure.

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I have had an amputation above the wrist.

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I have had a seizure in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week).

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Box and Blocks Test (BBT) from baseline to 1 week post-intervention

Secondary study objectives

Change in Action Research Arm Test (ARAT)

Change in Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale

Change in Cortical activity ratio (CAR)

+12 more

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

Active Control

Group I: ReIn-hand and robotExperimental Treatment2 Interventions

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.

Group II: ReIn-HandActive Control1 Intervention

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Robot

2019

N/A

~190

0 / 19Eligibility 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

The most common treatments for stroke, particularly those focusing on motor recovery and neuroplasticity, include physical therapy, occupational therapy, and device-assisted practice of activities of daily living (ADL). These treatments work by promoting neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for stroke patients as it helps in the recovery of motor functions and improves the ability to perform daily activities. Device-assisted ADL practice, in particular, facilitates motor recovery by providing repetitive, task-specific training that mimics normal movement patterns, thereby enhancing the brain's adaptive capabilities and improving functional outcomes.