30 Participants NeededMy employer runs this trial

Sensory Feedback for Stroke

SW
Overseen BySang Wook Lee, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: The Catholic University of America
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality can aid stroke survivors in regaining better control of their hand movements. Participants will use VR to practice hand movements, with some movements appearing larger (Visual ROM augmentation) or smaller (Visual ROM reduction) than they are, to assess if this improves control. The trial seeks individuals who have experienced a stroke on one side of the brain and have had weakened muscles on that side for at least six months. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking advancements in stroke recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for stroke survivors?

Past studies have examined the use of visual range of motion (ROM) changes to aid stroke recovery. Although specific safety information for these treatments is limited, research on similar virtual reality methods indicates they are generally well-tolerated. For instance, studies have found that virtual reality rehabilitation can be as safe and effective, or even more effective, than traditional therapy.

This clinical trial is in the early stages and primarily aims to assess the treatments' safety for participants. Early trials like this one typically involve small groups to closely monitor any potential side effects. While detailed safety data is limited, the techniques used in this trial resemble other virtual reality therapies, which are considered safe for stroke patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the sensory feedback approach for stroke rehabilitation because it offers a novel way to enhance movement recovery. Unlike traditional therapies that focus primarily on physical exercises and manual feedback, this method uses visual range of motion (ROM) augmentation and reduction. This technique provides real-time visual cues to patients, potentially accelerating brain adaptation and improving motor function. By directly involving the brain's visual processing in rehabilitation, it could offer faster and more effective recovery compared to standard treatments like physiotherapy or occupational therapy.

What evidence suggests that this trial's treatments could be effective for stroke?

This trial will explore the effects of visual feedback on stroke recovery through two approaches: Visual ROM augmentation and Visual ROM reduction. Research has shown that visual feedback during stroke recovery can improve movement. Studies have found that enhanced visual cues, such as those in virtual reality (VR) systems, aid in learning and regaining motor skills. Specifically, stroke survivors using VR with enhanced visual feedback experienced significant improvements in hand movement. Additionally, visual feedback can reduce unwanted movements, like excessive trunk movement, leading to better rehabilitation outcomes. Overall, these techniques use visual cues to support movement and muscle control, offering promising benefits for stroke recovery.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 20-70 who had their first stroke affecting one side of the brain at least 6 months ago and have moderate arm weakness. People with other major health issues or recent strokes cannot join.

Inclusion Criteria

I am between 20 and 70 years old.
My arm function score is between 31 and 55 on the Fugl-Meyer scale.
I had my first stroke on one side of my brain over 6 months ago, causing weakness on one side.

Exclusion Criteria

Presence of concurrent severe medical illness
I cannot voluntarily move my fingers or thumb.
I have a serious injury or medical complication like a fracture or heart disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform hand movements in a virtual reality environment under different sensory feedback conditions

Periprocedural
Multiple sessions in VR environment

Follow-up

Participants are monitored for changes in muscle activation and joint range of motion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Visual ROM augmentation
  • Visual ROM reduction

Trial Overview

The study tests how changing visual feedback in virtual reality affects hand movement after a stroke. Participants will see either amplified or reduced finger movements while wearing a VR headset, to see if this helps improve motor control.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Visual ROM reduction followed by visual ROM augmentationExperimental Treatment2 Interventions
Group II: Visual ROM augmentation followed by visual ROM reductionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Catholic University of America

Lead Sponsor

Trials
15
Recruited
2,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

The Impact of Visualization on Stroke Rehabilitation in Adults

The key outcomes of interest are gains in motor function, mobility, and overall recovery rates, while secondary goals include quality of life, patient adherence ...

Does visual error augmentation offer advantages during ...

In this two-arm, randomized controlled trial, we explored the effect of visual error augmentation alone by visually shifting the paretic ...

Augmented visual feedback of movement performance ... - PMC

Increasing evidence suggests that use of augmented visual feedback could be a useful approach to stroke rehabilitation.

Examining the effectiveness of virtual, augmented, and mixed ...

[16] showed that the developed VR system can improve the motor control of stroke patients after VR proprioception feedback training. Virtual ...

Evaluating the Effectiveness of Immersive Virtual Reality ...

The findings of this study revealed that VR-based hand games with enhanced visual training feedback substantially improved hand motor function ...

Examining the effectiveness of virtual, augmented, and mixed ...

Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial ...

Upper-Limb Robot-Assisted Therapy Based on Visual Error ...

The purpose of this study was to investigate the effect of upper-limb robot-assisted therapy based on visual error augmentation in virtual reality ...

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

This grant explores the prospects of artificially augmenting error as a means of enhancing the motor learning process and tests it on the recovering survivor ...