What side effects are associated with this type of intervention?

Common side effects of intensive rehabilitation therapies, such as those involving haptic robots with VR simulations, include muscle soreness, fatigue, and, in some cases, frustration or mental fatigue due to the intensity and repetitive nature of the exercises. Non-invasive neuromodulation techniques, like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), may cause mild headaches, scalp discomfort, or tingling sensations. These side effects are generally mild and temporary, but it is important for patients to be monitored closely to adjust therapy as needed.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for stroke treatments that directly involve haptic robots with VR simulations, adaptive algorithms, and haptic/visual feedback. However, broader stroke rehabilitation treatments often include physical therapy, occupational therapy, and the use of various assistive devices to improve motor function. These therapies aim to enhance neuroplasticity and motor recovery through repetitive, task-specific training. Emerging technologies in stroke rehabilitation, such as robotic-assisted therapy and virtual reality, are being studied for their potential to provide intensive, high-dosage training and improve outcomes, but specific FDA approvals for these advanced methods are still evolving.

What other types of research exist?

Promising, novel alternatives to Haptic Robots with VR Simulations for stroke patients in 2024 include external trigeminal neurostimulation, remote electrical neuromodulation, transcranial magnetic stimulation, and noninvasive vagus nerve stimulation. These methods offer advanced neuromodulation techniques that can aid in motor recovery and enhance neuronal plasticity.

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Robotic Rehabilitation

Robotic/Virtual Reality Therapy for Stroke (RAVR Trial)

N/A

Waitlist Available

Led By AM Barrett, MD

Research Sponsored by New Jersey Institute of Technology

Eligibility Criteria Checklist

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

Must have

Sufficient cognitive function to follow instructions

Be older than 18 years old

Must not have

Prior stroke with persistent motor impairment or other disabling neurologic condition

Receptive aphasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months post stroke

Awards & highlights

No Placebo-Only Group

Summary

This trial uses robotic gloves and virtual reality games to help stroke patients with weak hands regain movement and strength. The exercises are designed to make the brain and muscles work together to improve hand function. Robot-assisted therapy and virtual reality-based rehabilitation have been shown to be effective in improving hand function in stroke patients.

Who is the study for?

This trial is for individuals who have had a stroke within the last 7 to 30 days, can follow instructions, and have limited hand movement (Fugl-Meyer score ≤49/66). They must also be able to feel light touch and not have other serious illnesses or conditions that could interfere with therapy.

What is being tested?

The study compares early versus delayed rehabilitation using robots and virtual reality (VR) to improve hand function after stroke. It tests if intensive training during a critical period of brain recovery can better restore motor skills.

What are the potential side effects?

While specific side effects are not listed, participants may experience fatigue or discomfort from intensive therapy sessions. The robotic/VR system is designed to adapt to individual limitations which should minimize strain.

Eligibility Criteria

Inclusion Criteria

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

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I can understand and follow instructions.

Exclusion Criteria

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

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I have had a stroke or another neurological condition that still affects my movement.

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I have difficulty understanding spoken or written language.

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I have difficulty noticing things on one side of my body or severe loss of body awareness.

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I have severe arthritis that limits my arm and hand movements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months post stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months post stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months post stroke 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

Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force

Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension

Upper arm

+18 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Early Robotic/VR Therapy (EVR)Experimental Treatment1 Intervention

Subjects in this group will receive state-of-art inpatient usual care therapy plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated 5-30 days post stroke.

Group II: Dose-Matched Usual Physical Therapy CareExperimental Treatment1 Intervention

Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.

Group III: Delayed Robotic/VR Therapy (DVR)Experimental Treatment1 Intervention

Subjects in this group will receive state-of-art usual care therapy (inpatient and outpatient) plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated within 31-60 days post stroke.

Group IV: Usual Physical Therapy CareActive Control1 Intervention

Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dose-Matched Usual Physical Therapy Care

2018

N/A

~120

Delayed Robotic/VR Therapy (DVR)

2018

N/A

~120

Early Robotic/VR Therapy (EVR)

2018

N/A

~120

0 / 5Eligibility 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 recovery, particularly those involving haptic robots and VR simulations, focus on enhancing neuroplasticity and motor learning. These treatments use adaptive algorithms to tailor exercises to the patient's current abilities, gradually increasing difficulty to promote improvement. Haptic feedback provides tactile sensations that help reinforce correct movements, while visual feedback from VR simulations engages the brain's motor networks, aiding in the reorganization and strengthening of neural pathways. This approach is crucial for stroke patients as it maximizes the period of heightened neuronal plasticity post-stroke, leading to more effective and sustained recovery of motor functions.

Head-Mounted Display-Based Therapies for Adults Post-Stroke: A Systematic Review and Meta-Analysis.