What is the mechanism of action of this treatment?

Stroke rehabilitation often involves targeted exercises to improve motor function, such as repetitive hand and finger movements against various loads. These exercises work by enhancing neural plasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for stroke patients as it helps restore motor skills and improve coordination, thereby increasing independence and quality of life. The use of tools like the SPiRE Maestro Hand Exoskeleton can further aid in this process by providing consistent and precise movements, which are essential for effective rehabilitation.

What side effects are associated with this type of intervention?

Common treatments for stroke rehabilitation, particularly those involving targeted exercises to improve finger joint coordination, include physical therapy, occupational therapy, and the use of assistive devices like hand exoskeletons. Known side effects of these treatments are generally minimal but can include muscle soreness, fatigue, and, in some cases, temporary increases in pain or discomfort as the body adjusts to new movements and exercises. It is important for patients to work closely with their healthcare providers to monitor and manage any side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke rehabilitation, focusing on improving motor function and coordination. One notable approval is for robotic exoskeletons, which assist in physical therapy by providing support and enhancing movement in affected limbs. These devices, such as the SPiRE Maestro Hand Exoskeleton, are designed to improve finger joint coordination and overall hand function, contributing to better independence and quality of life for stroke survivors. Additionally, other approved therapies include constraint-induced movement therapy (CIMT) and various forms of physical and occupational therapy aimed at promoting neuroplasticity and functional recovery.

What other types of research exist?

Promising novel alternatives for stroke rehabilitation in 2024 include: 1) Robotic exoskeletons for assisted movement and strength training, 2) Virtual reality (VR) and augmented reality (AR) systems for immersive rehabilitation exercises, 3) Brain-computer interfaces (BCIs) to facilitate neuroplasticity and motor recovery, 4) Non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), and 5) Advanced neurorehabilitation software platforms that use artificial intelligence (AI) to personalize therapy programs.

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Exoskeleton

Hand Exoskeleton for Stroke Rehabilitation

N/A

Waitlist Available

Led By Na Jin Seo, PhD MS BS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)

Be older than 18 years old

Must not have

Inability to follow 2-step commands

Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the 1st half to the 2nd half of the 1-hour training session

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new exercise tool to help Veterans recovering from a stroke improve their finger movements. The tool uses special controllers to guide finger exercises, aiming to enhance hand function and independence.

Who is the study for?

This trial is for adult veterans who had a stroke between 1-6 months ago and can move their fingers somewhat (Chedoke-McMaster Hand Section Stage 2-4). It's not suitable for those who can't follow simple commands or have severe muscle stiffness preventing finger placement, or recent changes in spasticity medication.

What is being tested?

The SPiRE Maestro Hand Exoskeleton is being tested as a new rehabilitation tool to improve hand function by enhancing finger joint coordination in individuals recovering from a stroke.

What are the potential side effects?

While the trial description does not specify side effects, typical concerns with exoskeleton use may include discomfort at contact points, skin irritation, or fatigue due to training.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can move my fingers but with some difficulty.

Exclusion Criteria

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

Select...

I cannot follow 2-step commands.

Select...

My fingers are very stiff, making it hard to move them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the 1st half to the 2nd half of the 1-hour training session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the 1st half to the 2nd half of the 1-hour training session

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the 1st half to the 2nd half of the 1-hour training session 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 finger joint torque assistance

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: single armExperimental Treatment1 Intervention

All participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exoskeleton

2018

N/A

~70

0 / 3Eligibility 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

Stroke rehabilitation often involves targeted exercises to improve motor function, such as repetitive hand and finger movements against various loads. These exercises work by enhancing neural plasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for stroke patients as it helps restore motor skills and improve coordination, thereby increasing independence and quality of life. The use of tools like the SPiRE Maestro Hand Exoskeleton can further aid in this process by providing consistent and precise movements, which are essential for effective rehabilitation.

Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand.