75 Participants Needed

Augmented Visual Feedback for Stroke Rehabilitation

CD
KT
CC
Overseen ByCourtney Celian, MSOT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Augmented Visual Feedback for Stroke Rehabilitation?

Research shows that using visual feedback, like virtual reality, can help improve movement and motivation in stroke recovery. Studies have found that visual feedback can enhance motor learning and performance, leading to better movement control and increased range of motion in stroke patients.12345

Is augmented visual feedback safe for use in stroke rehabilitation?

The studies reviewed did not report any safety concerns related to the use of augmented visual feedback in stroke rehabilitation, suggesting it is generally safe for human use.12456

How does the treatment 'Augmented Visual Feedback for Stroke Rehabilitation' differ from other treatments for stroke rehabilitation?

This treatment is unique because it uses augmented visual feedback, including virtual reality and visual biofeedback, to enhance motor learning and motivation in stroke rehabilitation. Unlike traditional methods, it provides real-time visual cues to correct movement errors, potentially improving motor performance without the need for expensive robotic devices.12457

What is the purpose of this trial?

The goal of this research study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment.In conjunction with the Leap, large, three dimensional work spaces can provide an immersive and virtual augmented environment for rehabilitation. Previously, experiments have utilized the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel, more capable apparatus for studying error augmentation.This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching intervention. The healthy arm will only participate in 1 visit with an intervention with and without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2 groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual Feedback group.The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will administer outcome assessments at 3 time points: a.) prior to intervention, b.) post intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.The Acute Arm will have a less structured intervention that will occur while the participant is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations, midpoint evaluations will take place at a maximum of once per week if the participant's schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour sessions occurring according to the availability of the participant at the rate of no more than 2 sessions in a 24 hour period.Investigators hope to investigate these questions:1. Can the movement of healthy individuals be characterized with error augmented visual feedback and veridical visual feedback?2. Will error augmented visual feedback or veridical visual feedback result in greater movement ability improvement? Investigators hypothesize that in the Chronic Arm, those what trained with error-augmented visual feedback will have improved movement ability compared to those who trained with veridical visual feedback.3. Is treatment with the looking glass and leap system feasible with an inpatient population?Investigators hypothesize that this treatment will be feasible for an inpatient population.

Research Team

JP

James Patton

Principal Investigator

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

Eligibility Criteria

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.
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Timeline

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

Treatment Details

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.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: Chronic Veridical Visual FeedbackExperimental Treatment1 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 FeedbackExperimental Treatment1 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 FeedbackExperimental Treatment1 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 FeedbackExperimental Treatment1 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: HealthyActive Control1 Intervention
Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials
212
Recruited
17,900+

Findings from Research

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.
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]
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.
Upper Extremity Functional Rehabilitation for Stroke Survivors Using Error-Augmented Visual Feedback: Interim Results.Porta, F., Celian, C., Patton, JL.[2021]
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.
Visually displayed EMG feedback: single case studies of hemiplegic upper extremity rehabilitation.Gianutsos, JG., Eberstein, A., Krasilovsky, G., et al.[2019]

References

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. [2019]
Upper Extremity Functional Rehabilitation for Stroke Survivors Using Error-Augmented Visual Feedback: Interim Results. [2021]
Closed-Loop Task Difficulty Adaptation during Virtual Reality Reach-to-Grasp Training Assisted with an Exoskeleton for Stroke Rehabilitation. [2022]
Visually displayed EMG feedback: single case studies of hemiplegic upper extremity rehabilitation. [2019]
Effects of different types of augmented feedback on intrinsic motivation and walking speed performance in post-stroke: A study protocol. [2022]
Personalized Touch-Based Exergame System for Unilateral and Bilateral Rehabilitation Training. [2022]
A review of the evidence underpinning the use of visual and auditory feedback for computer technology in post-stroke upper-limb rehabilitation. [2016]
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