Augmented Visual Feedback for Stroke Rehabilitation

Overseen By Courtney Celian, MSOT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Bilateral paresis, Severe sensory deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks for Chronic Arm; 1-3 weeks for Acute Arm

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if augmented visual feedback (a therapy involving enhanced visual cues) can improve arm movement in stroke survivors. Participants will use a virtual reality setup with a Leap Motion device and the Looking Glass to perform reaching exercises. The trial includes one group of healthy individuals and two groups of stroke survivors—those who experienced a stroke more than 8 months ago and those who had a stroke within the last 8 months. It suits stroke survivors who can perform certain arm movements and wish to improve their mobility. Participants will attend sessions using either enhanced visual cues or regular feedback to identify which method is more effective. As an unphased trial, this study provides a unique opportunity for stroke survivors to contribute to innovative research and potentially enhance their recovery journey.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had Botox injections in the affected arm within the past 4 months, you would not be eligible to participate.

What prior data suggests that this augmented visual feedback system is safe for stroke rehabilitation?

Research has shown that enhanced visual feedback, which improves movement visibility during therapy, is generally safe. One study found that using this feedback in balance training was both safe and more effective than traditional methods for improving balance, with participants experiencing no harmful side effects.

For accurate visual feedback that displays exact movements, studies on virtual reality therapy also suggest safety. Research indicates that virtual reality can be a helpful and safe tool in stroke recovery, improving movement without causing harm.

Both types of visual feedback have been used in various settings without major safety concerns, suggesting they are well-tolerated by users, including those recovering from a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance stroke rehabilitation using technology. Unlike traditional physical therapy, which primarily relies on repetitive exercises, this trial uses augmented visual feedback to encourage different movement patterns. Additionally, the trial incorporates devices like Leap Motion and the Looking Glass system to provide real-time, visual biofeedback, making therapy more interactive and engaging. By directly reflecting or augmenting arm movements, these methods aim to improve motor function more effectively and could potentially speed up recovery for stroke patients.

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

Research has shown that enhanced visual feedback can improve balance and movement during rehabilitation. For stroke patients, visual feedback has proven effective in boosting recovery, particularly in enhancing balance and walking. This trial will compare different types of visual feedback systems. Participants in the "Chronic Augmented Visual Feedback" and "Acute Augmented Visual Feedback" arms will use augmented reality systems, which have helped individuals regain better movement in their arms and legs after a stroke. Meanwhile, participants in the "Chronic Veridical Visual Feedback" and "Acute Veridical Visual Feedback" arms will experience visual feedback that directly reflects their actual arm movements. Studies have found that virtual reality rehabilitation can significantly improve physical abilities in stroke survivors, including better arm movement and overall functional skills. Both types of visual feedback have shown promise in aiding stroke recovery. ^{1 6 7 8 9}

Who Is on the Research Team?

James Patton

Principal Investigator

Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)

Are You a Good Fit for This Trial?

This trial is for adults who had a stroke at least 8 months ago, can move their shoulder and elbow against gravity to reach forward, but not for those with severe muscle stiffness, recent Botox in the arm, or other rehab treatments. It excludes pregnant women, children, prisoners, people with multiple strokes or severe sensory issues in the limb.

Inclusion Criteria

You had a stroke 8 months ago.

I'm not familiar with the term "FMUE 15-50." Can you provide more context or information so I can assist you better?

You are able to move your shoulder and elbow to reach 30 cm in different directions.

Exclusion Criteria

You are not able to stay in the required testing positions.

You have major loss of feeling in the affected limb.

You have very severe muscle stiffness that makes it hard to move your elbow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in reaching interventions using the Leap motion tracker and Looking Glass system. The Chronic Arm undergoes structured sessions over 6-8 weeks, while the Acute Arm has less structured sessions during inpatient stay.

6-8 weeks for Chronic Arm; 1-3 weeks for Acute Arm

3 sessions per week for Chronic Arm; up to 2 sessions per day for Acute Arm

Follow-up

Participants are monitored for changes in movement ability and arm test scores after treatment. Chronic Arm follow-up occurs 2 months post-intervention.

2 months for Chronic Arm

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Visual Feedback
• Bimanual Balanced Reaching With Visual Biofeedback
• Healthy Comparative Reaching Task
• Leap Motion Device
• Looking Glass
• Veridical Visual Feedback

Trial Overview

The study tests if augmented visual feedback using Leap Motion and Looking Glass helps improve movement more than standard feedback. Participants are divided into healthy individuals; acute stroke survivors (recent stroke); and chronic survivors (older stroke), each receiving different interventions.

How Is the Trial Designed?

Group I: Chronic Veridical Visual Feedback Experimental Treatment 1 Intervention

Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.

Group II: Chronic Augmented Visual Feedback Experimental Treatment 1 Intervention

Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.

Group III: Acute Veridical Visual Feedback Experimental Treatment 1 Intervention

Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.

Group IV: Acute Augmented Visual Feedback Experimental Treatment 1 Intervention

Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.

Group V: Healthy Active Control 1 Intervention

Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

A randomized controlled trial involving subjects training in a virtual environment showed that both groups improved in motor recovery after three weeks of training, suggesting that rehabilitation can continue to be effective even after a plateau is reached.

The group using Error-Augmentation (EA) demonstrated consistent advantages in improvement, indicating that visual feedback can enhance rehabilitation outcomes similarly to robotic-assisted therapies, while also introducing greater variability in performance between trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Extremity Functional Rehabilitation for Stroke Survivors Using Error-Augmented Visual Feedback: Interim Results. Porta, F., Celian, C., Patton, JL.[2021]

In a pilot study with 5 chronic stroke patients, position feedback during upper limb reach training led to improvements in kinematic variables, indicating enhanced motor learning.

Subjects required only a small percentage (7.4% to 14.7%) of training time for position feedback, yet all showed increased movement performance, suggesting that immediate feedback on errors can effectively aid rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. Molier, BI., Prange, GB., Krabben, T., et al.[2019]

In a study involving 5 patients with hemiplegic upper limb motor disorders post-stroke, visually displayed EMG feedback significantly improved motor control, particularly in elbow movements, with all patients regaining control of at least one targeted activity.

While shoulder flexion and finger extension showed clinical improvements in some patients, only specific cases could be statistically linked to EMG gains, indicating that the effectiveness of the feedback varied among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visually displayed EMG feedback: single case studies of hemiplegic upper extremity rehabilitation. Gianutsos, JG., Eberstein, A., Krasilovsky, G., et al.[2019]

The study will involve 18 individuals with chronic stroke to compare the effects of three different types of augmented feedback on walking speed and motivation: simple visual feedback, basic virtual reality (VR), and VR exergames.

The research aims to fill a knowledge gap regarding how these different feedback methods influence rehabilitation outcomes, specifically focusing on improvements in walking speed and intrinsic motivation during recovery from stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of different types of augmented feedback on intrinsic motivation and walking speed performance in post-stroke: A study protocol. Alhirsan, SM., Capó-Lugo, CE., Brown, DA.[2022]

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Effectiveness of Augmented Reality in Stroke Rehabilitation

This study aims to review the effect of AR technology in the recovery of the upper and lower limb function in stroke patients.

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